ETHIOPIAN FOOD, MEDICINE AND HEALTHCARE ADMINISTRATION AND

CONTROL AUTHORITY

STANDARD OPERATING PROCEDURES FOR PHARMACEUTICALS GOOD

DISTRIBUTION AND STORAGE PRACTICES

April 2018

Addis Ababa, Ethiopia

Introduction

Distribution of pharmaceutical products is an important activity in the integrated supply-chain

management. Feeble points in the distribution processes of pharmaceutical products provide viable
ground for counterfeit, illegally imported, stolen and substandard medicines to enter the supply
chain. To maintain the original quality of pharmaceutical products, every party involved in the
distribution chain should comply with the applicable practices, legislation and regulations. Each
activity in the distribution of pharmaceutical products should be carried out according to the
principles of Good Manufacturing Practice (GMP), good storage practices (GSP) and good
distribution practices (GDP).

The Ethiopian Food, Medicine and Healthcare Administration and Control Authority is mandated
to ensure the availability of quality assured pharmaceutical products to the public. In addition, to
ensure the integrity, quality and responsiveness of the supply chain, the authority is required to
implement and enforce internal quality management systems in all importers and wholesalers of
pharmaceutical products. As part of this effort, the authority has developed model standard
operating procedures (SOPs) for pharmaceuticals good distribution practice, good storage
practices and other related activities with a view to integrate and standardize internal quality
assurance systems of pharmaceutical importers and wholesalers in Ethiopia.

Therefore, these model SOPs are prepared to guide pharmaceutical importers and wholesalers to
adapt them for their contexts. The pharmaceutical importers and wholesalers are expected to
implement the adapted SOPs and display the SOPs in the respective areas at all times. These SOPs
define and describe the functional relationships, the work processes, the roles and internal controls
that promote efficiency, transparency and accountability.
The following Model Standard Operating procedures are included in the document
1. Standard Operating Procedure for Pharmaceutical Storage Practice
2. Standard Operation Procedure for Receiving of Pharmaceutical products
3. Standard Operating Procedure for Dispatch and Transport
4. Standard Operating Procedure for Inventory
5. Standard Operating Procedure for Cleaning
6. Standard Operating Procedure for Self-inspection
7. Standard operating procedure for Corrective and Preventive Action
8. Standard Operating Procedure for Complaints Handling
9. Standard Operating Procedure for Return Products Handling
10. Standard Operating Procedure for Recall Handling
11. Standard Operating Procedure for Medicine Waste Handling and Disposal
12. Standard Operating Procedure for Security
Logo Document No: xxx
ORGANIZATION NAME Approved date:
Effective date:
Title: Standard Operating Procedure for Pharmaceutical Storage Revision No. 00 Page 1 of 7
Practice

Title: Standard Operating Procedure for Pharmaceutical Storage Practice Logo

Status: SOP No.

Prepared by Approved by Revised by Version No.

Name: Name Name Effective date:

Sig: Sig: Sig: Review date:

Date: Date: Date: Supersedes:

Table of Contents

1. Purpose ................................................................................................................................2
2. Scope...................................................................................................................................2
3. Responsibilities....................................................................................................................2
3.1. Warehouse manager ..........................................................................................................2
3.2. Technical Director ............................................................................................................2
4. Definitions ...........................................................................................................................2
5. Materials and Equipment’s ..................................................................................................3
6. Procedures ...........................................................................................................................3
6.1. Warehouse manager ..........................................................................................................3
6.2. Technical manager ............................................................................................................4
7. Distribution .........................................................................................................................5
8. Records ...............................................................................................................................5
9. Revision History ..................................................................................................................5
Reference ................................................................................................................................5
Annexes ..................................................................................................................................6
Annex 1: Defined storage Instructions and Meanings ...............................................................6
Annex 2: Rejected products log ...............................................................................................6
Annex 3: Cleaning log sheet ...................................................................................................7

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1. Purpose
The purpose of this SOP is to describe the storage requirements of medicines and medical
products at warehouse and during transportation in the distribution channel.

2. Scope
This SOP is applicable to institutions involved in storage and distribution of stores
pharmaceutical products. These include but not limited to manufacturers, importers, distributors
and medicine retail outlets.

3. Responsibilities

3.1. Warehouse manager

 Receive and store medicines according to their storage conditions
 Daily Monitoring of temperature and relative humidity of the store
 Store products at their appropriate place.

3.2. Technical Director

 Ensure that medicines are stored according to their storage condition
 Document periodic monitoring record
 Ensure that this SOP is followed
 Update this SOP when required

4. Definitions
The definitions given below should be used in the context of this SOP only.
4.1. Expiry date: The date given on the individual container (usually on the label) of a
pharmaceutical product up to and including the date on which the product is expected to
remain within specifications, if stored correctly. It is established for each batch by
adding the shelf-life to the date of manufacture.
4.2. Packaging material: Any material, including printed material, employed in the
packaging of a pharmaceutical product, but excluding any outer packaging used for

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transportation or shipment. Packaging materials are referred to as primary or secondary

according to whether or not they are intended to be in direct contact with the product.
4.3. Pharmaceutical product: Any product intended for human use, presented in its finished
dosage form, which is subject to control by pharmaceutical legislation in either the
exporting or the importing state and includes products for which a prescription is
required, products that may be sold to patients without a prescription, biologicals and
vaccines.
4.4. Storage: The storing of pharmaceutical products and materials up to their point of use.
4.5. Supplier: A person or entity providing pharmaceutical products and materials upon
request. Suppliers may be agents, brokers, distributors, manufacturers or traders. Where
applicable, suppliers should be authorized by a competent authority.

5. Materials and Equipment’s

 Calibrated Digital thermo-hygrometers
 Logbooks
 protective or working garments
 Temperature and humidity recording log sheet

6. Procedures

6.1. Warehouse manager

 Receive pharmaceutical shipments in clean receiving bay as per receiving SOP (SOP
No…..) and check label such as Name, strength, batch number, expiry date according to
supplier dispatch document ( packing list, sales invoice etc).
 Store products on clean, undamaged pallets and according to product specification.
 Maintain adequate space between the rows of stored products for cleaning, monitoring
and inspection.
 Ensure safe and appropriate storage of pharmaceutical products.
 Properly handle and store NPS drugs in compliance with international conventions, and
national laws and regulations.

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 Store separately highly toxic and radioactive materials, and other hazardous, sensitive
and/or dangerous materials and pharmaceutical products in dedicated area that is subject
to appropriate additional safety and security measures.
 Follow appropriate stock rotation to ensure that the oldest stock sold first within its shelf
life and moved to the front of the picking face and the new stock put to the back.
 Store recalled and return products according in a dedicated area under key and lock and
clearly labelled.
 Periodically segregate and records damaged and expired products.
 Ensure cleanliness of warehouse, monitor as per cleaning schedule and records are
maintained as per Annex 3.
 Control and monitor room temperature and relative humidity using calibrated thermo-
hygrometer and records are maintained as per the temperature and RH log sheet.
 Check the condition of newly arrived cold box that contain the product.
 Ensure safe and appropriate storage of cold chain pharmaceutical products.
 check and ensure cold chain products are not placed directly against the refrigerator side
or back wall or near the cooling plate.
 Maintained sufficient space around the cold chain products for air to circulate.
 Check the expiry date of the cold-chain products on a regular basis.

6.2. Technical manager

 Ensure medicines are stored according to their storage condition.
 Ensure daily monitoring of temperature and relative humidity is carried out.
 Ensure handling of NPS according to national legislation.
 Ensure proper handling of recall, returned, expired products.
 keep all monitoring records for at least the shelf-life of the stored pharmaceutical
products pluses one year.
 Ensure cold-chain medicines are stored and managed properly.
 Ensure this SOP is followed and updated when required.

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 Monitor proper transfer of the products to the cold room.

7. Distribution

This SOP distributed to:

 Quality assurance department/general managing/ technical manager offices
 Warehouse manger

8. Records
8.1.After the completion of each activity, all documents and correspondence should be
recorded and filed in folder.
8.2.File numbers should be kept electronically and/or in hard copy for easy of tracing folders.
8.3.The change histories of this SOP should be kept and filed properly including all versions
8.4.The different versions should be kept for _____years in traceable manner.

9. Revision History

Revision number Summary of change Effective date

R0 New SOP To be assigned
R1
R2
R3

Reference
1. http://www.fmhaca.gov.et/documents/GDP,%20GSP%20and%20Recale%20Guideline%202
015.pdf
2. WHO, guide to good storage practices for pharmaceuticals, series No 908.2003.

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Annexes

Annex 1: Defined storage Instructions and Meanings

Storage condition on the label Interpretation

Freeze/Freezer The temperature is -20°C to -10°C
Refrigerator The temperature is 2°C to 8°C
Cold place The temperature is ≤ 8°C
Cool place The temperature is 8°C to 15°C
Room temperature The temperature is 15°C to 30°C
Do not store over 30°C From +2°C to +30°C
Do not store over 25°C From +2°C to +25°C
Do not store over 15°C From +2°C to +15°C
Do not store over 8°C From +2°C to +8°C
Do not store below 8°C From +8°C to +25°C
Protect from moisture ≤ 60% relative humidity
“Protect from light” To be provided to the patient in a light-resistant container
Do not store over 30°C From +2°C to +30°C
Do not store over 25°C From +2°C to +25°C
Do not store over 15°C From +2°C to +15°C

Annex 2: Rejected products log

Rejected Product Product Batch Quantity Reason Removed Disposition

by and name strength no. by and by RP
date date (R / D)*

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R (Returned to supplier), D (Destroyed)

Annex 3: Cleaning log sheet

Type of cleaning: Daily Monthly Annual

Date Cleaning carried Area cleaned Cleaning agent used Performed by Checked by
out

Reviewed by:___________________________Date:________________________

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Logo Document No: xxx
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Title: Standard Operating Procedure for Monitoring Revision No. 00 Page 1 of 8
Temperature and Relative humidity

Title: Standard Operating Procedure for Monitoring Temperature and Relative Logo
humidity

Status: SOP No.

Prepared by Approved by Revised by Version No.

Name: Name Name Effective date:

Sig: Sig: Sig: Review date:

Date: Date: Date: Supersedes:

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Temperature and Relative humidity

Table of Contents

1. Introduction ........................................................................................................................... 3

2. Purpose .................................................................................................................................. 3

3. Scope ..................................................................................................................................... 3

4. Responsibility ........................................................................................................................ 4

4.1 Store keeper .................................................................................................................... 4

4.2 Technical manager .......................................................................................................... 4

5. Materials and equipment ........................................................................................................ 4

6. Procedure ............................................................................................................................... 4

6.1 Monitoring and recording of room temperature ............................................................... 4

6.2 Monitoring and Recording of Refrigerators and Freezer Temperature ............................. 5

6.3 Humidity control and monitoring .................................................................................... 5

7. Distribution ............................................................................................................................ 6

8. Records .................................................................................................................................. 6

9. Revision History .................................................................................................................... 6

10. Reference ........................................................................................................................... 7

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Logo Document No: xxx
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Temperature and Relative humidity

1. Introduction
Temperature and/or relative humidity monitoring is essential in warehouses and storage
facilities housing sensitive medical equipment and pharmaceuticals product. Failure to store
such items within the specified temperature range may affect their quality and effectiveness.
Failure to monitor and record temperatures and relative humidity accurately can mean that
health professionals may be unaware of these potential effects on medical product. This may
well include the monitoring and control of room temperature storage required by the
manufacturer. This Temperature and relative humidity monitoring SOP directs how to monitor
temperature and/or relative humidity of medical product during storage, transportation and
distribution.
2. Purpose
This Standard Operating Procedure (SOP) describes the procedure when monitoring and
recording of temperatures and/or relative humidity of medical products.

3. Scope
This SOP applies to the monitoring of temperature and relative humidity for medical
product during the storage, distribution and transportation

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Temperature and Relative humidity

4. Responsibility
4.1 Store keeper
 Monitor the room temperature and refrigerator temperature regularly
 Record the reading of temperature and/or relative humidity
 Report any discrepancy occurred
4.2 Technical manager
 Ensures the room and refrigerator temperature monitored regularly
 Ensures records are kept
5. Materials and equipment
 Temperature and humidity recording log sheet
 Stationeries
 Calibrated thermometer
 Calibrated hygrometer
6. Procedure
6.1 Monitoring and recording of room temperature
6.1.1 Ensures calibrated temperature monitoring device positioned according to the
result of mapping exercise.
6.1.2 Control and monitor temperatures using calibrated monitoring device.
6.1.3 Conduct monitoring at points representing the extremes of the temperature
range (hot spots or cold spots)
6.1.4 Record twice daily and it contains date, time, minimum and maximum
temperatures and name and sign of person recording. (Annex1)
6.1.5 Check the thermometer used for monitoring at suitable predetermined
intervals.
6.1.6 Record the results of such checks and retain the record.
6.1.7 Calibrate thermometer at least [put period re-calibration date]
6.1.8 Report any deviation to technical manager
6.1.9 Keep all monitoring records for a period of [put document retain period]

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Temperature and Relative humidity

6.1.10 Investigate any deviation and take appropriate corrective and preventive
action.
6.1.11 Record the action taken.
6.2 Monitoring and Recording of Refrigerators and Freezer Temperature
6.2.1 Calibrated control sensors/thermometer positioned at the hot and cold spots
determined by temperature mapping,
6.2.2 Ensures control sensors independent of the temperature monitoring system
6.2.3 Check the maximum, actual and minimum fridge temperature between
intervals.
6.2.4 Record the Maximum, Current/Actual, and Minimum temperature twice daily.
(Annex1)
6.2.5 Keep temperature logs close to the refrigerator/freezer (but not inside)
6.2.6 Use a separate temperature record for each refrigerator/freezer. (Annex1)
6.2.7 Calibrate the thermometer at least [put re-calibration date]
6.2.8 Record any activity which may affect the temperatures recorded e.g. tidying,
re-stocking, cleaning, defrosting at the time it takes place.
6.2.9 The temperature log signed and date by individuals checks.
6.2.10 Investigate out of specification reading and take corrective action and
preventive action.
6.2.11 Record action taken.
6.2.12 Out of specification reading exists for several time for an unknown reason,
take advice from the manufacturer regarding the stability of product/Excursion
time/.
6.2.13 Keep all monitoring records for [put document retain period].
6.3 Humidity control and monitoring
6.3.1 Ensures calibrated relative humidity monitoring device placed at the storage
area.
6.3.2 Monitor the reading of the relative humidity between intervals.

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Temperature and Relative humidity

6.3.3 Record the reading of the relative humidity measuring device twice daily
(Annex 2)
6.3.4 Keep all monitoring records for [put document retain period].
6.3.5 Investigate out of specification reading and take corrective and preventive
action
6.3.6 Record the action taken.

7. Distribution
This SOP will be distributed to:
 Technical manager office
 Store keeper/warehouse manager

8. Records
1. After the completion of each activity, all documents and correspondence should be
recorded and filed in folder.
2. File numbers should be kept electronically and/or in hard copy for easy of tracing
folders.
3. The change histories of this SOP should be kept and filed properly including all
versions.
4. The different versions should be kept for _____years in traceable manner.

9. Revision History

Revision number Summary of change Effective date

R0
R1
R2
R3

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Temperature and Relative humidity

10. Reference
 GSP, GDP and pharmaceuticals recall guideline, 2015.
 WHO Annex9, model Good Cold Chain Management for Temperature- Time-
Sensitive Pharmaceutical Products
 Good Cold Chain Management for Temperature-Sensitive Pharmaceutical
Products, Edition 2, 2017. Republic of Lebanon Ministry of public health,
Quality assurance and pharmaceuticals product program.

Annexes
Annexure 1: Room and refrigerator temperature recording format
Max and Min temperature /acceptance limit/_________________
Month________________________________
Id.no____________________________

Date Time Actual Action/comment or

Temperature Taken by outcomes when
reading Name Sign temperature
excursion/

Annexure 2: Relative humidity recording format

Max and Min relative /acceptance limit/_________________
Month________________________
ID.no_________________________

Date Time Actual Action/comment or

relative Acceptance Taken by outcomes
humidity limit

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Temperature and Relative humidity

Min. Max. Name Sign

Temp Temp
.

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Title: Standard Operating Procedure for Dispatch and Transport Logo

Status: SOP No.

Prepared by Approved by Revised by Version No.

Name: Name Name Effective date:

Sig: Sig: Sig: Review date:

Date: Date: Date: Supersedes:

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Table of Contents
1. Background ............................................................................................................................3

2. Purpose ...................................................................................................................................3

3. Scope ......................................................................................................................................3

4. Acronyms and Abbreviations ..................................................................................................3

5. Responsibility .........................................................................................................................4

6. Materials and equipment .........................................................................................................4

7. Procedures ..............................................................................................................................5

8. Document distribution ............................................................................................................7

9. Records...................................................................................................................................7

10. Amendment histories .............................................................................................................8

11. References .............................................................................................................................8

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1. Background

[Company name] has prepared this SOP to ensure quality and integrity of pharmaceutical
products and materials that can be affected by lack of control during storage and poor
compliance to good distribution practices. Distribution is an important activity in the integrated
supply-chain management of pharmaceutical products. [Company name] are generally
responsible for the handling, storage and distribution of such products. In some cases, however, a
person or entity is only involved in and responsible for certain elements of the distribution
process.

This document sets out appropriate steps to assist in fulfilling the responsibilities involved in the
different aspects of the distribution process within the supply chain and to avoid the introduction
of counterfeits into the marketplace via the distribution chain. The involvement of unauthorized
entities in the distribution and sale of pharmaceutical products is a particular concern.

2. Purpose

The purpose of this procedure is to describe the dispatching and transportation activities of
pharmaceutical products.
3. Scope

This procedure is applicable to the entire process during dispatch and transportation of
pharmaceuticals products.

4. Acronyms and Abbreviations

SIV Store Issue Voucher

SOP Standard Operating Procedure
GDP Good Distribution Practice
GSP Good Storage Practice

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5. Responsibility

Title Responsibility
Warehouse manager  Counting and verification of items during dispatching.
 Handover of items to driver/receiver.
 Verification of items against the issue order and SIV.
Deliverer  Transfer the items to the receiving storekeeper by availing
himself when all items are unloaded, counted and verified
with documents.
 Counting and verification with the documents before
transport the product.
 Monitoring temperature and humidity during transit
 Informing any discrepancy during transit
 Bring proof of delivery from the health facility.
Warehouse operatives  Arrange product during handover
 Picking and dispatching of pharmaceuticals
Storage and distribution  Confirm the delivery and discrepancies if any.
officer
Technical manager  Approves (sign and stamp) the sales and requisition form.
 Check customer qualification procedure

6. Materials and equipment

 Dispatch product Report format/log book

 Store Issue Voucher (SIV)
 Discrepancy record format
 Deliverer log book

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7. Procedures

1.1. Prepare requisition form when receiving a request by telephone or formal letter or any
other means of communication from the qualified customer (including their transportation
mechanisms) and hand over to the warehouse operatives.
1.2. Warehouse operatives pick and collect items from the storage area or warehouse as exactly
mentioned on the requisition form/issue order (check the expiry date and batch number).
1.3. Selected products are placed on dispatch area (care must be given for cold chain items) and
arranged by category convenient for count.
1.4. Count and verify the dispatch products against requisition form/issue order by the
warehouse manager.
1.5. Technical manager confirms the correctness of the dispatch count and approves the
requisition/dispatching process by checking all necessary information presented on the
requisition form.
1.6. Requisition form/issue order is then sent to store clerk for the preparation of store issue
voucher.
1.7. After preparation of the store issue voucher the finance officer prepares invoice based on
the requisition form/SIV.
1.8. Prior to calling driver or the authorized receiver into dispatch area and given the invoices
for the items to be delivered. Records for dispatch product must be retained, stating at least:
 Date of dispatch; complete receiver organization name and address (no acronyms),
 Type of entity responsible for the transportation, telephone number and names of
contact persons;
 Complete receiver organization name, address (no acronyms), and level of the
receiver (e.g., retail pharmacy, hospital);

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 Product description, e.g., product name, dosage form and strength (if applicable);
quantity of the products, i.e., number of containers and quantity per container (if
applicable); batch number and expiry date (where not possible at dispatch, this
information should at least be kept at receipt to facilitate traceability).
 Applicable transport and storage conditions; and
 Unique number to allow identification of the delivery order;
1.9. The receiver counts the dispatched items and verify against the invoices.
1.10. Pack the delivery and make ready for delivery. Delivery documentation is ready (check all
partially filled cartons are packed and sealed properly, after count, in front of the
driver/receiver or the qualified customer).
1.11. Both the receiver and storekeeper sign the invoices.
1.12. One original and one copy of the invoices are given to the deliverer to be submitted to the
receiver, one copy of the invoice will be given to the technical manager of the customer
and sign on both invoice of the original and copy.
1.13. Items are loaded on the vehicle. Loading on vehicle should be arranged in such a way that
items for the nearest receiver are loaded last and for the remotest first.
1.14. Distribution of invoices and SIV: Storekeeper, finance, documentation follow up and two
copies of invoice for receiver/driver.
1.15. Deliverer of vehicles identifies themselves and present appropriate documentation to
demonstrate that he/she had authorized to transport the load.
1.16. The deliverer record (discrepancy report format) and report damage containers and any
other event or problem that occurs during transit to the relevant department, entity or
authority, and investigated.
1.17. Deliverer passes the invoice to responsible person at receiver’s institution.
1.18. Unload the items from vehicle. The receiver is responsible for unloading of items.
1.19. The deliverer together with the receiver’s responsible person count and verify items against
invoice.

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1.20. If there is no discrepancy or defect the responsible person from the receiver signs and put a
seal on the invoices for approval of receipt.
1.21. If there is discrepancy (overage/shortage) or defect the receiver is required to specifically
mention the same on the location provided on the invoice and signed by both the deliverer
and the receiver.
1.22. Deliverer receives a copy of stamped invoice from the receiver of the products.
1.23. Up on return deliverer submits the invoices for documentation (including discrepancy
(damaged, overage/shortage) for follow up if any.
8. Document distribution

The procedure shall be distributed to:

 General Manager office

 Technical manager office

 Warehouse manager office
 Sales man/promoters office
 Finance department
9. Records

1.24. After the completion of each activity, all documents and correspondences should be
recorded and filed in a proper folder. File numbers should be kept electronically and/or in
hard copy for ease of tracing folders.
1.25. The amendment and revision of this procedure is the responsibility of the technical
manager with the direction of the top management of the institution. Amendment of this
procedure will be done when it is deemed necessary and the revision shall not be beyond
2 years.
1.26. The change histories of this SOP should be kept and filed properly including all
versions.

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10. Amendment histories

This SOP will be revised every two years or amended as appropriate.

Revision Number Summary of Changes Effective date
R0
R1
R2

11. References

 WHO good distribution practices for pharmaceuticals product, annex 5, TRS No. 957,
2010.
 GDP, GSP and recall guidelines, Ethiopian Food, Medicine and Healthcare
Administration and Control Authority, 2015, first edition.

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Title: Standard Operating Procedure for Receiving Revision No. 00 Page 1 of 11

Title: -Standard Operation Procedure for Receiving

Status: Doc No:

Prepared by Approved by Revision No :

Name: Name: Effective date:

Position Position Supersedes:

Sig: Sig:

Date: Date:

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Table of Contents

1. Abbreviation............................................................................................................................ 3

2. Introduction: ............................................................................................................................ 3

3. Purpose: .................................................................................................................................. 3

4. Scope: ..................................................................................................................................... 3

5. Responsibilities ....................................................................................................................... 3

6. Materials ................................................................................................................................. 4

7. Procedure ................................................................................................................................ 4

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1. Abbreviation

COA Certificate of Analysis

EFMHACA Ethiopia Food, Medicine and healthcare Administration and Control Authority
of Ethiopia
PO Purchase Order
ISO/IEC International Standard Organization/International Electronics Cooperation
SOP Standard Operation Procedure

2. Introduction:

Pharmaceutical company conducts good receiving of Pharmaceutical products, in accordance

with a predetermined procedure to verify that its operations continue to comply with the
requirements of the management system.

3. Purpose:

The purpose of this receiving SOP is to mitigate risks to receive pharmaceutical products and lay
down the procedures to monitor the implementation and compliance with good receiving.

4. Scope:

This SOP is applying on organization engaged in receiving of Pharmaceutical products.

5. Responsibilities

5.1. Storekeeper;

 Get copies of invoices/documents of newly received products and conduct physical

inspection on vehicle and medicinal products
 Receiving, recording and reporting of new arrivals.
5.2. Technical Manager:

 Ensure all documents of newly arrived products

 Ensure receiving vouchers /recorded reports
 Ensure appropriate segregations of products

3
6. Materials

 Receipt voucher
 Receipt log book
 Inspection check list
 Bin Card/Stock Card/any other record System
7. Procedure

7.1. Arrange warehouse space before the arrival of Pharmaceutical products

7.2. Get copies of invoices/documents of the consignment (like invoice, COA, et) and
examine carefully whether the products belong to them, whether products as per
purchase order/request and also check whether they come from approved vender, if not
immediately inform to technical manager/purchase team.
7.3. Conduct physical Inspection on incoming trucks for the following:
 The trucks must van/ be covered.
 Floorboards are dry and clean.
 No evidence of chemical spills, garbage, waste.

 Insect and rodent activity

7.4. Unload the shipment at receiving area/bay and inspect the condition of the shipment to
ensure:
 All products are on clean pallets.
 Separate damaged/suspected /altered products during transportation
 Check availability of Temperature monitoring equipment if required,
7.5. Notify the technical manager/ warehouse manager the result of the physical inspection
7.6. Count the products and compare the quantity, name, and lot numbers to the information
stated on the shipping documents/delivery invoice and company purchase order (PO).
7.7. Complete the receiving log sheet/receipt invoice and signs for approval of receipt.

4
 7.8. When a discrepancy exist technical / warehouse manager/purchase team will verify
whether the driver/carrier is accountable or not. If the driver is accountable, a
discrepancy verification report is filled in and an appropriate measure will be taken.
7.9. A copy of record of Incoming products will be given to technical/warehouse manager
and the driver/deliverer
7.10. On receipt of damaged shipment/defective package/suspected products take a photo of
the damaged product defective package/suspected products and ensure the truck driver
signs the receiving document as evidence and store to designated area and notify
purchasing manager /technical manager to return or destroy, if important
7.11. Label damaged product, defective package/suspected products with all information:
name, lot number, quantity, invoice number & date and store at designated area
7.12. Recorded pharmaceutical products on correspondent Bin cards /appropriate sheets and
attach a card on each pallet containing that products.
7.13. De-dust all products before moving into the store
7.14. Arrange the items on pallets or other location according to the expiry and batch
number. Use the packing list for easy reference of batch number and expiry dates.
7.15. File all records
8. Reference

 ES ISO/IEC 17020:2012

5
 Annex1: Flowchart for warehouse receiving products

New arrival

Receive documents from Carrier/driver

Conduct inspection on vehicle

Unload pharmaceutical products

Check quantity against documents

Prepare receiving voucher

Give a one cope of receiving voucher to

driver/carrier and send other copy to
technical manager/purchase team

Store at appropriate place

Annex 2: Physical inspection checklist for receiving

6
7
SN Variables Yes No Not available
CONTENT FOR LABELLING
1 Is the labelling has an English /Amharic
language version?
2 Is the labels display the following information?
2.1 International Nonproprietary Name (INN) of
the active ingredients

2.2 Dosage form

2.3 Quantity of active ingredient(s) in the dosage

form and the number of units per package

2.4 Batch number

2.5 Date of manufacture

2.6 Expiry date (in clear language, not in code)

2.7 Pharmacopoeia standard (e.g. BP, USP,)

2.8 Instructions for storage

2.9 Name and address of the manufacturer

PHYSICAL INSPECTION FOR DOSAGE FORM

3.1) TABLETS and CAPSULES
S/N Variables

3.1.1 Is Tablets/ Capsules are identical in size and Yes No Not Available
shape?
3.1.2 Is Tablets/ Capsules are identical in color
(variation of shade of color from batch to batch

8
 may be normal. However, if it is within the
same batch it may indicate poor quality)?

3.1.3 Is Tablets/ Capsules markings are identical

(example : -lettering , numbering

3.1.4 Is there any defects (check for colored spots ,

hollows, fragments/ breaks, /friability behavior
/ , uneven edges , cracks , embedded or
adherent foreign matter, stickiness)?

3.1.5 Is there any odor when a sealed bottle is opened

except for flavored tablets and those with active
ingredients normally having a characteristic
odor?

3.1.6 Is there any odor after tablets have been

exposed to room air for 20 -30 minutes?

3.1.7 For capsules only is there any empty, broken,

crack and open capsule?

3.2) PARENTRAL FORMULATION

3.2.1 Is the solution free from un dissolved particles
(solutions should clear)?

3.2.2 Is the dry solids for uses in injections are

entirely free from visible foreign particles?

3.2.3 Is there any leaking containers (bottles, vials,

ampoules, bags etc)?

9
 3.3 ORAL LIQUID/SEMISOLID DOSAGE FORMS
3.3.1 Is the bottle size/shape the uniform?

3.3.2 Is there is a gas evolving when sample bottles

are opened that indicates fermentation?

3.3.3 Is there leakages, breakages, label deformities?

3.3.4 Is there any color changes in the same batch?

3.3.5 Is there any foreign particles

10
 Annex 3: Record of Incoming Goods (RIG)

Name the organization: _____________________________

Document no. (invoice, etc.): ________________________

Name and tel. no. of the person who delivered the pharmaceutical products__________________ signature-----------------Track
number---------------

Ser.no. Product Batch

P Quanti PO Number Vehicle Rodent/pest Damaged Discrepanc Remark
Received name No. ty visual activities Quantity y
date receiv inspectio
ed n

Name and signature of Storekeeper/receiver __________________________________

11
Logo Document No: xxx
ORGANIZATION NAME Approved date:
Effective date:
Title: Standard Operating Procedure for Inventory Revision No. 00 Page 1 of 5

Title: Standard Operating Procedure for Inventory Logo

Status: SOP No.

Prepared by Approved by Revised by Version No.

Name: Name Name Effective date:

Sig: Sig: Sig: Review date:

Date: Date: Date: Supersedes:

Table of Contents
1. Introduction .........................................................................................................................2

2. Purpose ................................................................................................................................2

3. Scope ...................................................................................................................................2

4. Responsibility ......................................................................................................................2

5. Material and equipment ........................................................................................................3

6. Procedure .............................................................................................................................3

7. Distribution ..........................................................................................................................4

8. Revision history ...................................................................................................................4

Annexures: ..................................................................................................................................5

Annexure 1: Format Sheet for Warehouse Periodic Inventory Count .......................................5

1
Logo Document No: xxx
ORGANIZATION NAME Approved date:
Effective date:
Title: Standard Operating Procedure for Inventory Revision No. 00 Page 2 of 5

1. Introduction
A critical activity of the inventory control function is to verify that the physical inventory matches
inventory records. Physical inventories ensure and promote confidence in the inventory records.
There are two kinds of physical inventory count. Complete physical inventory count which also
known as fiscal count or wall to wall count where all products are counted at the same time. It is
takes place at least once a year
Cyclic or random physical inventory: Selected products are counted and checked against the stock
keeping records on a rotating or regular basis throughout the year.it is usually appropriate at
facilities that manage larger quantities of products. It is a continuous counting, for example every
week or each month by dividing the inventory in different group, with reconciliation of
discrepancies.it is take place without interrupting normal operations.
2. Purpose
The purpose of this SOP is to describe the inventory processes bring the demand management
functions of the companies and to verify physical inventory with the quantity on bin/stock card

3. Scope
The scope of this SOP applies to perform counting of all or part of inventory of the organization
engaged in Storage, transportation and distribution of medical products.

4. Responsibility
4.1.The inventory committee/officers responsible to:
4.1.1 Conduct the annual or as needed physical inventory in accordance with the
procedures.
4.1.2 Verify physical counts with forms and if necessary make adjustments to till 10%
deviation and consider recount if it is beyond this value.
4.1.3 Report the inventory report to the technical manager or other responsible body as
needed.
4.1.4 Investigate and review all previous and current error or discrepancies occurred
during inventory, fix it and report deviation to the technical manager or other the
responsible body.

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Logo Document No: xxx
ORGANIZATION NAME Approved date:
Effective date:
Title: Standard Operating Procedure for Inventory Revision No. 00 Page 3 of 5

4.2. The store manager responsible to:

4.2.1. Maintaining and updating the inventory records such as bin cards throughout the
year and obsolete items.
4.2.2. Classifying of stocks for counting based on health values and business criticality.
4.3. The technical manager or other responsible body responsible to:
4.3.1 Develop annual inventory plan and procedure.
4.3.2 Select appropriate staff to as the Inventory committee/ officer as needed.
4.3.3 Assure and verify that the inventory is performed and the records are maintained.
4.3.4 Provision training for store manager or inventory committee/ officer as needed.
4.3.5 Keep stock cards securely.

5. Material and equipment

 Stationary materials
 Inventory sheet formats
 Bin card/stock cards
 Computer as needed

6. Procedure
6.1. Classifying of stocks for counting based on health values and business criticality.
6.2. Maintaining and updating the inventory records such as bin cards throughout the year and
also for discarded/obsolete items.
6.3. Conduct the annual or as needed physical inventory in accordance with the procedures as
per plan and as per health values and business criticality
6.4. Verify physical counts with forms and if necessary adjust till 10% deviation.
6.5. Perform and submit an inventory report to the technical manager or other responsible
body as needed.
6.6. Check that the inventory is performed and the records are maintained.

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Logo Document No: xxx
ORGANIZATION NAME Approved date:
Effective date:
Title: Standard Operating Procedure for Inventory Revision No. 00 Page 4 of 5

6.7. Conduct a second recount if differences occur. If differences still occur after a second
recount of specific storage bin card, the entire batch of that product be counted in an
attempt to locate the error.
6.8. Conduct count to the entire stock of that products if then the difference still evident.
6.9. Investigation include reviewing all previous receipt and issued transaction on the material
code, any entry error, any discrepancies occurred during receipt, issue, reject and return
of that material, if the error is found fix it accordingly.
6.10. If still error is found, the committee raise deviation report (DR) and contact inventory
with warehouse manager and account manager to clear the stock difference.
6.11. Use blue or black pen only to fill in quantity or stock data. Each page must have count
date, the initial and signature in the space provided (refer annex 1).

7. Distribution
This document is distributed to

 Technical managing office

 Warehouse manger
 Inventory committee

8. Revision history
Revision number Summary of change Effective date
R0
R1
R2
R3
R4

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Logo Document No: xxx
ORGANIZATION NAME Approved date:
Effective date:
Title: Standard Operating Procedure for Inventory Revision No. 00 Page 5 of 5

Annexures:

Annexure 1: Format Sheet for Warehouse Periodic Inventory Count

Title: warehouse periodic inventory count sheet format

Item code
Month: Year:
prepared by: Signature: Date:
Product unit Batch Expired manufact Qty. Qty Complete balanc differ
name no Manufact date urer received issued /cyclic e ence
ured date count

5
Logo Name of organization: Document No:
Approved date:
Effective date
Title: Cleaning Procedure Revision No. 00 Page 1 of 4

Title: Standard Operating Procedure for Cleaning Logo

Status: SOP No.

Prepared by Approved by Revised by Version No.

Name: Name Name Effective date:

Sig: Sig: Sig: Review date:

Date: Date: Date: Supersedes:
1. Introduction
Cleaning is the removal of gross contamination, organic material, and debris from the
premises or respective structures, via mechanical means like sweeping (dry cleaning) and/or
the use of water and soap or detergent (wet cleaning). Pharmaceutical Premises and storage
facilities should be clean and free from litter and dust. Cleaning equipment should be chosen
and used in order not to be a source of contamination.
2. Purpose
The purpose of this SOP is to ensure that the medical product store is maintained clean, tidy
at the highest level of cleanliness
3. Scope
This SOP applied in all the [company XXX] warehouse that describe the methods by which
the cleaning of floors, walls, windows, shelves and stock will be done in the medicine store.
4. Responsibility
 Cleaners are responsible to follow the SOP
 It is the responsibility of the head of medicine store to ensure that these procedures
are followed

5. Equipment and material

 Sponge mop
 Rubber mop
 Broom
 dustbin
 Disinfectant and Detergents
 Personal Protective equipment

1
Logo Name of organization: Document No:
Approved date:
Effective date
Title: Cleaning Procedure Revision No. 00 Page 2 of 4

6. Procedure
6.1. All areas in which medicinal products are stored or held (i.e. goods inwards and receipt
areas, storage areas, quarantine areas and dispatch areas and delivery vehicles) should
be cleaned on an on-going basis.
6.2. The [company] execute a cleaning schedule as required (i.e. on a daily, weekly,
monthly and annual basis
6.3. Use protective equipment like gloves, aprons, boots, face mask etc., as necessary
during cleaning procedures
6.4. All cleaning chemicals and materials are properly labelled and stored separately from
medical warehouse/ kept in utility room
6.5. Daily cleaning basis
6.5.1. All rubbish and non-essential product packaging and wrapping should be
removed from the warehouse and disposed off.
6.5.2. Sweep floors of all storage areas receiving, dispatch areas every morning.
6.5.3. Clean shelves and stock after cleaning/sweep the floors
6.5.4. Dust all shelve in the medicine store with a dry duster
6.5.5. Avoid messing up the labels of containers
6.5.6. Squeeze the mop or duster hard to leave it almost dry before cleaning shelves
and containers
6.5.7. All waste bins should be emptied and fresh bin liners put in place
6.6. Cleaning floors under the pallet [Monthly cleaning basis]
6.6.1. Remove the pallets and clean the floor of all storage area
6.6.2. Start sweeping from the furthest point of the store
6.6.3. Collect clean water for a quantity enough to clean the store
6.6.4. Collect a clean mop and soap to use for mopping the floors
6.6.5. Dissolve soap in the clean water
6.6.6. Squeeze the mop as dry as is possible before mopping the floor
6.6.7. Do not use dirty water
6.7. Wall and window cleaning [Monthly cleaning basis]
6.7.1. Store person shall cover all shelves and pallets laying on by polythene sheet
before cleaning.

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Logo Name of organization: Document No:
Approved date:
Effective date
Title: Cleaning Procedure Revision No. 00 Page 3 of 4

6.7.2. Remove free dust and dirt using a dry duster

6.7.3. Apply window cleaner onto clean cloth and wipe off the dirt from the window
6.7.4. Use water and hose for cleaning the outside of high windows.
6.7.5. Make sure the windows are tightly closed
6.7.6. Wipe away dirt from the walls using a mop and clean water with soap or
detergent
6.8. Tube lights & high area [Annually basis]
6.8.1. Switch of the power supply and clean high-level areas clean high-level areas by
using clean and dry closes.
6.9. All cleaning recorded in the Cleaning Log (Annex 1 ---/----). This should include a
description of the area cleaned and cleaning agents used.
6.10. The person performing the cleaning sign and date the log.
6.11. The cleaning should be checked by a second person and this check should be recorded
in the log.
6.12. Cleaning records should be reviewed on a regular basis and this review should be
recorded on the Cleaning Log

7. Document distribution
 Warehouse manager
 Janitors

3
Logo Name of organization: Document No:
Approved date:
Effective date
Title: Cleaning Procedure Revision No. 00 Page 4 of 4

ANNEX 1: CLEANING PROCEDURE

Form No: _____________________

Date Cleaning agent used Area cleaned Name Cleaner Time

Reviewed by:____________ Checked by______________

Signature and date________ Signature and date_________

4
Logo Document No: xxx
ORGANIZATION NAME Approved date:
Effective date:
Title: Standard Operating Procedure for Self-Inspection Revision No. 00 Page 1 of 18

Title: Standard Operating Procedure for Self-inspection Logo

Status: SOP No.

Prepared by Approved by Revised by Version No.

Name: Name Name Effective date:

Sig: Sig: Sig: Review date:

Date: Date: Date: Supersedes:

Disclaimer: This is a model standard operating procedure. It incorporates generic guidance

principles only. Firms are encouraged to adapt their own SOPs as necessary to suit their in-
house procedures.

1
Logo Document No: xxx
ORGANIZATION NAME Approved date:
Effective date:
Title: Standard Operating Procedure for Self-Inspection Revision No. 00 Page 2 of 18

Table of Contents

1. Introduction ................................................................................................................... 3
2. Purpose .......................................................................................................................... 3
3. Scope ............................................................................................................................. 3
4. Acronyms and Abbreviations ......................................................................................... 3
5. Definition....................................................................................................................... 3
6. Responsibility: ............................................................................................................... 4
7. Material and equipment:................................................................................................. 4
8. Procedure ....................................................................................................................... 5
9. Distribution .................................................................................................................... 6
10. Revision history.......................................................................................................... 6
11. References: ................................................................................................................. 6
12. Annexes ..................................................................................................................... 7

2
Logo Document No: xxx
ORGANIZATION NAME Approved date:
Effective date:
Title: Standard Operating Procedure for Self-Inspection Revision No. 00 Page 3 of 18

1. Introduction:
Pharmaceutical company conducts self - audit periodically, in accordance with a
predetermined schedule and an internal procedure, internal audits to verify that its operations
continue to comply with the requirements of the management system.

2. Purpose:
The purpose of this SOP is to lay down procedures to conduct self- inspection (Internal-audit)
to monitor the implementation and compliance with good distribution and storage practices,
principles and to propose necessary corrective measures.

3. Scope:
This SOP applies to conduct self -inspection of good storage, transport and distribution
practices of medical products.

4. Acronyms and Abbreviations

CAPA Corrective and preventive action
EFMHACA Ethiopian Food, Medicine and Healthcare Administration and Control
Authority
GDP Good Distribution practice
GSP Good storage practice
QA Quality assurance
SOP Standard Operating Procedures

5. Definition
 Audit Means a systematic and independent examination to determine whether quality
activities and related results comply with planned arrangements and whether these
arrangements are implemented effectively and are suitable to achieve objectives. When
addressing the regulatory requirements, the term 'inspection' has been used to indicate
the same meaning as the term 'audit'.
 Auditee means any organisation whose quality systems are to be audited for
compliance with the relevant regulatory requirements.
 Auditor means a person with relevant qualifications and competence to perform audits
or specified parts of such audits and who belongs to or is authorised by the auditing
organisation.

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Logo Document No: xxx
ORGANIZATION NAME Approved date:
Effective date:
Title: Standard Operating Procedure for Self-Inspection Revision No. 00 Page 4 of 18

 Lead auditor means an auditor designated to manage an audit process (also known as
an audit team leader).
 Minor deviation means deviation from standard operating procedure or guidelines
which cannot lead to what is described under major or critical
 Major deviation means any deviation from the established procedure, process, system
and practice
 Critical deviation means critical point is any non-conformance, which can affect the
purity, strength and safety of the medicines, which pose serious health risk to the users.

6. Responsibility:

6.1. Head- Quality assurance/quality manager/Technical manager shall be:

6.1.1. Responsible to establish audit team
6.1.2. Responsible for approval of annual calendar for internal audit
6.1.3. Responsible for ensuring the conduction of internal audit as per schedule
6.1.4. Responsible for review and approval of summary report of internal audit report.

6.2. The audit Team shall be:

6.2.1. Responsible for conducting the audit as per schedule.
6.2.2. Responsible for checking the compliance of observations made during previous
audit
6.2.3. Responsible for preparation of internal audit report
6.3. The Auditee shall be:
6.3.1. Responsible for implementing the corrective action recommendation by audit team
6.3.2. Responsible for preparation of audit compliance report
6.3.3. Responsible to coordinate auditors and provide required information
7. Material and equipment:
 Stationary materials
 Checklists
 Previous audit report/external audit report/customer audit report
 National GDP and GSP guidelines and/or international recognized guidelines

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Logo Document No: xxx
ORGANIZATION NAME Approved date:
Effective date:
Title: Standard Operating Procedure for Self-Inspection Revision No. 00 Page 5 of 18

8. Procedure
8.1. Annual calendar for internal audit will be prepared by [Quality assurance/ technical
manager] and approved by responsible head (Refer Annexure-1)
8.2. During Internal audit, check compliance level of audits done by any external agency or
regulatory body and access the compliance level of audit carried by customers
8.3. Apart from annual calendar, audits may be carried out when there are any failure/
compliant/recall/regulatory findings etc.
8.4. The list of auditors (Annexure-2) will be prepared from different departments
considering members from cross functional area with no conflict of interest.
8.5. Internal auditors shall be selected by quality assurance/quality manager/Technical
manager based on his/her experience, qualification, subject matter expertise and
knowledge.
8.6. Each area shall be audited/ inspected at least once in six months.
8.7. The parameters to be covered shall include at least good storage practice, good
distribution practice, quality management system, personnel etc.
8.8. The audit scope may be narrowed down to cover only a particular segment/activity as
needed.
8.9. The auditors jointly inspect the respective areas as per checklist as applicable
8.10. Auditors shall verify data integrity related issues of each department as applicable
8.11. The observations may not be limited to the checklist. It can be extended towards the
criticality of findings.
8.12. The auditor report will be agreed on findings based on factual evidence necessary to
record all the observation in audit report.
8.13. The deficiencies observed during audit shall be categorized as Critical. Major, Minor
(other) deficiencies.
8.14. Based on the observations in the audit, the auditor shall prepare the separate audit
report as per the format given in annexure I and send a copy to the auditee [within
agreed working days] of audit date.
8.15. A copy of audit report shall be submitted to [Head of Quality assurance/Technical
manager] depending on the size of the organization. The audited department shall send
their CAPA plan within 15 days after receipt of audit report.
8.16. Follow up will be organized after the execution of CAPA.

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ORGANIZATION NAME Approved date:
Effective date:
Title: Standard Operating Procedure for Self-Inspection Revision No. 00 Page 6 of 18

8.17. Audit report and compliance report should be available for regulatory review.
9. Distribution
This SOP should be distributed to
 Technical managing office
 Warehouse manger
 Quality assurance department or General managing office
 To other necessary departments

10. Revision history

Revision number Summary of change Effective date
R0 New SOP To be assigned
R1
R2

11. References:
1. Ethiopian Food, Medicine and Health Care Administration and Control Authority,
Good Storage, Distribution and Pharmaceutical Recall guideline, 2014
2. World Health Organization: Good Storage Practice Guidelines

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Logo Document No: xxx
ORGANIZATION NAME Approved date:
Effective date:
Title: Standard Operating Procedure for Self-Inspection Revision No. 00 Page 7 of 18

12. Annexes
Annexure 1: Annual Calendar Format for Internal Audit
SN Department Jan Feb mar App may June July Aug Sep Oct Nov Dec
1. Warehouses
2. Distribution
and delivery
4. Procurement

Annexure 2: Format for list of Auditors

SN Name of auditors Department Name and department for audit

1.
2.
3.

Annexure 3: Format For Audit Report and Compliance report

Date of inspection: __________________________

Members of inspection team: __________________
Auditee department: _________________________
Reason for self-audit: ________________________
Status of Previous self-inspection: _________________________________________
SN Observation Category (Critical, Major and Other)

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ORGANIZATION NAME Approved date:
Effective date:
Title: Standard Operating Procedure for Self-Inspection Revision No. 00 Page 8 of 18

Annexure 4: Corrective and preventive action plan for self-inspection

Department: ________________________________

Focal person: _______________________________

SN Category Observations Proposed Indicator for Proposed Status

CAPA accomplishment closing date (closed or
pending)

Annexure 5: Checklist for premises & Facilities, and Sanitation & hygiene

SN Premises and Facilities

1. Unauthorized access to all areas of the authorized premises is prevented In NC NA
2. Receiving and dispatch bays protect products from prevailing weather
conditions
3. Segregated areas are designated for the storage of any product suspected
of falsification, returned product, rejected product, product awaiting
disposal, recalled product
4. Radioactive materials other hazardous products and products presenting
special risks of fire or explosion are stored in a dedicated area(s) with
appropriate safety and security measures
5. There is adequate separation between the receipt and dispatch areas and
storage areas
6. Rest, wash and refreshment rooms for employees are adequately
separated from the storage areas
7. Is there receiving SOP and there check list that should be filled during
receiving of products, is record maintained
8. Is there approved supplier list
9. Is there Dispatch SOP and there check list that should be filled during
dispatching of products, is record maintained
Sanitation and Hygiene

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ORGANIZATION NAME Approved date:
Effective date:
Title: Standard Operating Procedure for Self-Inspection Revision No. 00 Page 9 of 18

1. Procedures relating to personnel hygiene like health, hygiene and

clothing are
established and observed
2. Storage of food, drink, smoking materials or medication for personal use
in the storage areas is prohibited
3. Cleaning instructions and records are in place
4, Facilities are designed and equipped so as to afford protection against the
entry of insects, rodents or other animals
5, A preventive pest control programme is in place

Annexure 6: Checklist for temperature & environmental monitoring and equipment &
computer system

SN Temperature and environmental control In NC NA

1. Suitable equipment and procedures are in place to ensure adequate
control of the environment
2. Storage areas are temperature mapped for all seasons
3. Temperature monitoring equipment is located according to the results of
the mapping exercise
4. Controls are adequate to maintain all parts of the relevant storage area
within defined temperature, humidity or light parameters
5 Equipment used to control or to monitor the environment, are calibrated
and their correct operation and suitability is verified at defined intervals
by the appropriate methodology
6 Appropriate alarm systems are in place to provide alerts when there are
deviations from pre- defined storage conditions
7 Alarms are regularly tested
8 Power back generator or other means
Equipment and computer systems
1 Planned preventive maintenance is in place for key equipment
2 Calibration of equipment is traceable to a primary standard
3 Adequate records of repair, maintenance and calibration activities for

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ORGANIZATION NAME Approved date:
Effective date:
Title: Standard Operating Procedure for Self-Inspection Revision No. 00 Page 10 of 18

key equipment is made and the results are retained

4 Detailed written descriptions of the systems are available (describing the
principles, objectives, security measures and scope of the system and the
main features, how the computerized system is used and the way it
interacts with other systems
5 Data is entered into the computerized system or amended only by
persons authorized to do so
6 Data is secured by physical or electronic means against wilful or
accidental damage
7 Data is protected by backing up at regular intervals

Annexure 7: Checklist for Documentation, records, supplier & customer qualification

and Receipt of Goods

SN Documentations IN OUT NA
1. Documents are/ is retained for a period stated in national legislation
but at least for five years at a separate, secure location
Standard Operating Procedures
2. SOPs are reviewed regularly and kept up-to-date
3. SOPs are approved, signed and dated by appropriate authorized
persons
4. Superseded or obsolete SOPs are removed from workstations
Records
5. For any transaction in medicinal products received, supplied or
brokered, records are kept either in the form of purchase/sales
invoices, delivery slips, or on computer or in any other form
6. Records include the following information:
 Date
 name of the medicinal product
 quantity received, supplied or brokered
 name and address of the supplier, broker or consignee, as
appropriate

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ORGANIZATION NAME Approved date:
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 batch number where required

7. Distribution records contain sufficient information on distributors and
directly supplied customers (with addresses, phone and/or fax
numbers inside and outside working hours, batches and quantities
delivered), including those for exported products and medicinal
product samples
Distribution Operation /supply chain operation
8. All medicinal products distributed in Ethiopia have a marketing
authorization/ Waiver granted by the EFMHACA
9. Supplier Qualification
10. All supplies of medicinal products are obtained only from persons/
organizations who are in possession of an import/ wholesale
distribution authorization, or who are in possession of a
manufacturing authorization which covers the product in question
11. The purchase of medicinal products is controlled by written
procedures
12. The supply chain of medicinal products/pedigree is known and
documented
13. Appropriate qualification is performed prior to any procurement
14. Qualification and approval of suppliers is controlled by a standard
operating procedure
15. The results of qualification and approval of suppliers are
periodically rechecked
Qualification of Customers
16. Medicinal products are only supplied to persons/organizations who
are themselves in possession of a distribution authorization or who
are authorized or entitled to supply medicinal products to the public
17. Qualification of customers and periodic re-checks include:
 Requesting copies of customer's authorizations
 Verifying status on an authority website
 Requesting evidence of qualifications or entitlement according to

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national legislation.
 Qualification of customers are appropriately documented
 Additional Questions which might be asked for verification:
Receipts of Goods
18. Ensured that the arriving consignment is correct, the medicinal
products originate from approved suppliers and have not been
damaged or altered during transportation
19. Medicinal products which require special storage or security
measures, are transferred to appropriate storage facilities
immediately after appropriate checks have been conducted
20. In the event of any suspicion of falsified medicinal product, the
batch is immediately segregated
21. In the event of any suspicion of falsified medicinal product, the
batch is immediately reported to the EFMHACA
22. In the event of any suspicion of falsified medicinal product, the
batch is immediately reported to the marketing authorization holder
(where applicable)
Incoming containers of medicinal products are cleaned, if necessary,
before storage.

Annexure 8: Checklist for inspection Storage and Distribution Practice

SN Storage IN NC NA

1. Medicinal products are stored separately from other products

2. Medicinal products are protected from harmful effects of light,
temperature, moisture or other external factors.
3. Attention is paid to products where specific storage conditions are
required
4. Stock rotation according to the expiry dates of batches of medicinal
products is performed ("first expired first out" –FEFO- basis.)
5. Medicinal products beyond their expiry date or shelf life are withdrawn
immediately from saleable stock either physically or through other

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equivalent electronic segregation.

6. Physical removal of unsuitable stock is performed regularly
7. Medicinal products are not stored directly on the floor.
8. Stock inventories are performed regularly (timings are defined using a
risk based approach)
9. Inventory irregularities are investigated and documented
10. Medicinal products are stored separately from other products
Segregation of Goods
11. Segregation is provided for the storage of rejected, expired, recalled or
returned products and suspected falsified medicinal products.
12. Any system replacing physical segregation such as electronic segregation
based on a computerized system provides equivalent security and is
validated
Destruction of obsolete goods
13. Medicinal products intended to be destroyed are kept separately and
handled in accordance with a written procedure.
14. Destruction of medicinal products is in accordance with EFMHACA
disposal guidelines and/ or international requirements for disposal of
such products
15. Records of all destroyed medicinal products are maintained
Complaints IN NC NA
16. A written procedure is in place for the handling of complaints
17. In the case of a complaint about the quality of a medicinal product, the
manufacturer and/or marketing authorization holder is informed without
delay
18. A person is appointed for handling the complaints with sufficient
supporting personnel
19. Any complaint concerning a potential product defect or a potential
falsified product is recorded with all the original details and investigated
20. The national competent authority is notified without delay in case of a
potential product defect or a potential falsified product

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21. Any product distribution complaint is thoroughly investigated and

appropriate follow-up actions are taken after investigation and evaluation
of the complaint
Returned Medicinal Products
22. Written procedures are in place for the handling and acceptance of
returned
23. Medicinal products which have left the premises of the distributor are only returned
medicinal products to saleable stock if:
 The medicinal products are in their unopened and undamaged
secondary packaging and in good condition
 Demonstrated that the medicinal products have been transported,
stored and handled under proper specified/predefined conditions
 The distributor has reasonable evidence that the product was supplied
to that customer
 The batch number of the dispatched product is known
 A copy of the original delivery note is attached
 There is no reason to believe that the product has been falsified
 There is evidence that the product has been stored within the
authorized storage conditions throughout the entire time
 A risk assessment is performed by taking into account the product
concerned, any specific storage requirements and the time elapsed
since the medicinal product was originally dispatched
Suspected falsified medicinal products
24. The staff is aware of the risks of falsified medicinal products entering the
supply chain
25. A procedure is in place describing immediate information to
EFMHACA/regional regulatory bodies and, where applicable, the
marketing authorisation holder of the medicinal products they identify as
falsified or suspect to be falsified
26. Any suspected falsified medicinal products found in the supply chain is
immediately physically and securely segregated from legitimate medicinal

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products
27. Record available when there is suspecsion
Medicinal Product Recalls
28. There is a written procedure for the management of recalls
29. The management of recalls and its effectiveness is periodically tested and
evaluated by Mock Recall
30. Any recall operation is recorded at the time it is carried out
Transportation
Vehicles and equipment
31. Required storage conditions are maintained during transportation
32. Vehicles and equipment are suitable and appropriately equipped to prevent
exposure of the products to conditions that could affect their quality and
packaging integrity, and to prevent contamination of any kind
33. Procedures are in place for the operation and maintenance of all vehicles
and equipment, including cleaning and safety precautions
34. Validated temperature-control systems (e.g. thermal packaging,
temperature controlled containers, and refrigerated vehicles) are used to
ensure correct transport conditions
35. If refrigerated vehicles are used temperature mapping is performed under
representative conditions including seasonal variations
36. Equipment used for temperature monitoring during transport within
vehicles and/or containers, is maintained and calibrated at regular intervals
at least once a year
37. If cool-packs are used in insulated boxes, they are located such that the
product does not come in direct contact with the cool-pack
38. If cool-packs are used in insulated boxes, staff is trained on the procedures
for assembly of the insulated boxes (seasonal configurations) and on the
reuse of cool-Packs.
Delivery
39. Delivery drivers (including contract drivers) are trained in the relevant
areas of GDP

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40. Deliveries are made directly to the address stated on the delivery note
41. Deliveries are handed into the care of the consignee.
42. Deliveries are not left on alternative premises
Deviations
43. Deviations are reported to the distributor and recipient
44. Where necessary in the case of deviations, the manufacturer of the
medicinal product is contacted for information about appropriate steps to
be taken
45. Container and packaging is selected based on:
 the storage and transportation requirements
 the space required for medicines
 the anticipated external temperature extremes
46. A document is enclosed to ascertain the following:
 Date
 Name and pharmaceutical form of the medicinal product
 Batch number at least for products bearing the safety features, where
required
 Quantity supplied
 Name and address of the supplier
 Name and delivery address of the consignee (actual physical storage
premises, if different)
 applicable transport and storage conditions
47. Containers bear labels providing sufficient information on handling and
storage requirements and precautions
48. Containers bear labels enable identification
49. Requirements laid down by the concerned member states are met
50. Transportation is performed in safe, dedicated and secure containers and
vehicles
Annexure 9: Checklist for Quality Management System and Personnel
SN Quality Management System In Out NA
1. Does the company have a written policy including management's active

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commitment to quality
2. Is the policy signed by top management
3. Is there an approved quality manual and written procedures describing all
related processes?
4. Do management reviews consider:
 Findings of internal audits, recommendations made and corrective
actions taken?
 The overall effectiveness of the system in achieving quality objectives?
 Opportunities for updating and/or improving the system?
5. Is there a copy of the manufacturers’ documents (such as COA or COC)
supplied with each delivery?
6. Is there procedure for corrective and preventive actions
7. Trend Reports of findings and recommendations from Regulatory
Inspection of the past 2 years
8. Certificate of Competency displayed and displayed Certificate of
Competency validity documentation of disposition of out dated products
maintained for 3 years
Personnel
9. Organizational structure of the distributor is defined in an organizational
chart.
10. The responsibility, role and interrelationships of all personnel is clearly
indicated
11. Responsibilities and roles of employees working in key positions is defined
in written job descriptions, incl. deputyship arrangements
12. All personnel involved in wholesale distribution activities is qualified in
GDP requirements
13. Training includes aspects of product identification and avoidance of
falsified medicines entering the supply chain
14. Specific training is provided where indicated (e.g. handling of hazardous
products, radioactive materials as well as products presenting special risks
of abuse, narcotics

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or psychotropic substances, or temperature sensitive products)

15. Personnel receives initial and continuing training relevant to their tasks,
based on written standard operating procedures (SOPs) according to a
written training
programme
16. The practical effectiveness of training is periodically assessed and
documented
17. Has the company a sufficient number of qualified employees for these
operations?
18. Are employee training and qualification records maintained?
19. Are there procedures in place ensuring good hygiene of the personnel
20. Proper Personnel Identification, ethical behaving and clothing

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Action

Title: Standard operating procedure for corrective and preventive action Logo

Status: SOP No.

Prepared by Approved by Revised by Version No.

Name: Name Name Effective date:

Sig: Sig: Sig: Review date:

Date: Date: Date: Supersedes:

Disclaimer: This is a model standard operating procedure. It incorporates generic

guidance principles only. Firms are encouraged to adapt their own SOPs as necessary to
suit their in-house procedures.

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Action

Table of Contents

1 Introduction ..............................................................................................................3

2 PURPOSE.................................................................................................................3

3 SCOPE .....................................................................................................................3

4 Acronyms: ................................................................................................................3

5 Responsibility ...........................................................................................................3

6 Definition..................................................................................................................4

7 Procedures ................................................................................................................5

8 Distribution ...............................................................................................................9

9 Revision history ........................................................................................................9

10Annexures ....................................................................................................................9

11References....................................................................................................................9

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Action

1. Introduction

Corrective and Preventive actions are taken when deviations or nonconforming work
from the policies and procedures in the management system or technical operations have
been identified. The root cause investigation process will provide objective evidence to
implement corrective and possibly preventive actions as part of the CAPA system.
2. Purpose

The purpose of this SOP is to lay down the procedure for the initiation, evaluation,
approval, implementation, tracking, effectiveness and verification of effectiveness of
corrective and preventative actions, closure.

3. Scope

This SOP applies to all concerned departments of [ X pharmaceutical Facility]

4. Acronyms:

APQR Annual Product Quality Review

CAPA Corrective and Preventive Action

HOD Head of Department

OOT Out of Trend

OOS Out of Specification

QA Quality assurance

SOP Standard Operating Procedure

5. Responsibility

 Initiating department: responsible to initiate CAPA whenever there is non-

conformity work

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Action

 Respective department: Responsible to initiate, rectify non- conformity work

accordingly.
 Quality assurance unit (QA approver, QA reviewer, QA closure)/ Technical
manager/ general manager/CEO)
- Responsible to approve completeness, adequacy and, review
- Responsible to assure necessary corrective and preventive action are taken
and close the CAPA.
 Cross functional team: responsible to perform the recommended activity and
attach supporting documents.
6. Definition

6.1. Corrective and preventive action (CAPA): CAPA is a tool of quality

management system of implementation of corrective and preventative actions
resulting from the investigation of incident/recall/component rejection/out of
specification/change control/market compliant/internal or external audit
observation/Annual product quality review/regulatory compliance action/non-
compliance report/risk analysis/validation summary report.
6.2. Corrective Actions are taken to eliminate the root causes of deviations, and
should be based on good quality investigations.
6.3. Preventative action: Pro-active in nature which is action executed to eliminate
the cause of potential non-conformity and implemented independently from the
occurrence of deviations (Preventive action i.e. act on potential deviation) and
prevent occurrence.

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Action

7. Procedures

7.1. General CAPA management

7.1.1. All the corrective and preventative actions that are finalized as part of the respective
system or procedure shall be monitored through the CAPA management SOP.
7.1.2. Each department shall initiate their respective finalized CAPA’s as per the annex II
below.
7.1.3. All CAPA’s total time line period from initiation to closure shall not exceed 180
working days.
7.1.4. The time period from initiation to approval of the CAPA is 30 working days, 60
working days from approval of CAPA to closure of CAPA, 90 working days for
extension of closure.
7.1.5. Any supporting documents wherever required, has to be attached in their original
template or format, signed off and attached to CAPA initiated as applicable.

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Action

1.1 Intiation of CAPA

1.1.1 CAPA initiated in theinvestigation Incidents,OOS, OOT, Market compliants,

deviations, component rejections, change controls, internal audits , external audits,
validation, product recall, product quality review, risk analysis,or regulatory
compliance and informed to the concern person from the intiating department by
[QA personnel] (Equivalent personnel) responsible for the coordination of
CAPA.

1.1.2 The responsible person from the intiating department intiate the CAPA as per the
Annexure 2.

1.1.3 The CAPA intiator shall fill in the below given details in the template (Annexure
II) and forward the same to the HOD or designee.

1.1.4 Evaluation of CAPA by HOD of designee of intiator department

1.1.5 In case of any discrepancy observed, the HOD or his designee shall send back the
CAPA temepate for the intiator for corrections.

1.1.6 The initiatorrectifies the discrepancy and send back to HOD for review and
approval.

1.1.7 The HOD forwards the filled Template to QA approval for review and approved
the CAPA.

1.2 Review and Approval of CAPA by QA approver:

1.2.1 The QA approval review the CAPA for the completeness, adequacy and accuracy

1.2.2 On review of the above, the QA approver, approve the CAPA and sign off.

1.2.3 In case of any discrepancy noticed, the same shall be returned to both the initiator
and HOD for rectifications.

1.2.4 On rectifications of the discrepancies, the initiator shall forward the CAPA to the
HOD for the approval.

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Action

1.2.5 Up on approval by the HOD, QA-Approver shall review and approve the same.

1.2.6 On approval of CAPA, the QA-approver shall assign the CAPA number and the
CAPA number should be generated on logical order.

1.2.7 On approval, the QA Approver shall inform the concerned person of the initiating
department for the execution of the CAPA.

1.3 Execution of CAPA (Individual department and cross functional team)

1.3.1 The Initiator and concerned department perform the recommended activity and
attach the supporting document (if any) as mentioned in the CAPA temperate.

1.3.2 Any change in the existing systems, procedures or documents required based on
the recommended CAPA, shall be routed through SOP of change control.

1.3.3 If CAPA is related to certain department, the recommendations or action taken

shall be communicated to the respective departments.

1.4 Review of CAPA implementation by QA Reviewer

1.4.1 On completion of the implementation activity by the initiating department, the

QA reviewer review the implementation activities for the CAPA and supporting
documents of each department for the completeness, accuracy and adequacy.

1.4.2 In case any discrepancy noticed, send CAPA back to the respective initiating or
the cross function department for rectifications.

1.5 The initiating or cross functional department complete the rectifications and
send back the CAPA format to the QA reviser.

1.5.1 QA reviewer, review the same and sign off.

1.5.2 On successful review, the QA reviewer inform for CAPA effectiveness check to
the concerned department.

1.6 CAPA effectiveness verification by individual or cross functional

departments

1.6.1 Each department that has been assigned the CAPA implementation carry out the
effectiveness verification for their respective CAPA implemented.

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Action

1.6.2 Once done, each department attach any supporting documents against the
respective CAPA format and sign off.

1.7 Review of Effectiveness verification by QA Reviewer

1.7.1 On completion of the effectiveness verification activity by the initiating

department or the cross function team, the QA Reviewer review the effectiveness
verification and supporting documents for each department for completeness,
adequacy and accuracy.

1.7.2 In case discrepancy noticed, the same shall be informed to the respective cross
functional department for rectifications and the cross functional team shall
complete the rectification and send back CAPA template to QA reviewer

1.7.3 The QA reviewer, review the same and sign off.

1.8 Closure of the CAPA by QA closure

1.8.1 Based on the review by the QA reviewer, QA closure, close the CAPA with
comments and sign off.

1.9 Extension of the CAPA closure

1.9.1 If activities related CAPA are not executed within 60 working days, in such case
initiating department head shall request for extension with justification along with
proposed date for completion of the same.

1.9.2 Period implementation of CAPA and further extension shall be proposed based on
the risk assessment of existing process and impact on product quality.

1.9.3 QA approval shall review the reason and approve/reject the extension by signing
off.

1.9.4 On approval, the CAPA closure shall be extended by not exceeding by 90 working
days or can be with appropriate Justification of extension.

1.10 Review and Trending of CAPA

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Action

1.10.1 CAPA shall be reviewed by quality assurance every two weeks for its status, the
details for the same shall be provided to concern HOD, CEO and concerned
higher officials.

1.10.2 QA prepared Trends of CAPA on periodical basis by means of graphs/charts

including details of type and category and information.

2 Distribution
This SOP will be distributed to:

 Technical manager office

 All concerned departments
 Original copy: Quality assurance/Managing director

3 Revision history

Revision Summary of change Effective date

number
R0 New SOP To be assigned
R1
R2

4 Annexures
 Annexure 1: CAPA log
 Annexure 2: CAPA format

5 References
 World Health Organization: deviation handling and quality risk management
 ISO13485: Quality management System

Annexure 1: CAPA log

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Action

Date Product/system Tracking ref.No Reference Description Status Verifie

/Area of parent d/
Corrective Preventive Inv. format Corrective Preventive sign/da
action action Action action te
1.

2.

3.

Annex 2: CAPA Format

CAPA initiation
Source of information
CAPA No: Date:
Problem/observation/Information is related to:
 Equipment/process/vendor/material/ storage/warehouse/ distribution/….
 Feedback from regulatory agency/marketing/ managing directors
 Internal /external audit
 Any other source

Reference Document Number:

Brief description of parent document

Root cause summary:

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Action

Descriptive of corrective action:

Descriptive of preventive action:

Department: Initiated by: date

Review of the CAPA by HOD (head of department)

Review of CAPA ( comments)

Name: sign/date:
Approval of CAPA by QA
Review of comments

Name: sign/date:
CAPA implementation by initiating department
Corrective Action implemented:

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Action

Preventive action Implemented:

Reference document attached:

CAPA implemented by:

Name: sign/date
Review of CAPA implementation by QA
Review of corrective action implementation:

Review of preventive Action implementation:

Reviewed by Quality assurance:

Name: sign/date
Effectiveness check of the implemented CAPA by department
Effectivenesscheck comments

Effeteness check by:

Name: sign/date
Effectiveness check by QA

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Action

Effectiveness comment by QA

Checked by:

Extension of CAPA closure

Reason/ Justification of extension:

Approval of extension of closure:

Comments

Review and closure of CAPA

Comments

CAPA closed by: sign/ date

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Title: Standard Operating Procedure for Complaints Handling Logo

Status: SOP No.

Prepared by Approved by Revised by Version No.

Name: Name Name Effective date:

Sig: Sig: Sig: Review date:

Date: Date: Date: Supersedes:

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Table of Content
1. Background ............................................................................................................................3

2. Purpose ...................................................................................................................................3

3. Scope ......................................................................................................................................3

4. Acronyms and Abbreviations ..................................................................................................3

5. Definition ...............................................................................................................................3

6. Responsibility .........................................................................................................................4

7. Materials and equipment .........................................................................................................4

8. Procedure flow chart ...............................................................................................................5

9. Procedure................................................................................................................................6

10. Document distribution ...........................................................................................................7

11. Records .................................................................................................................................7

12. Amendment histories .............................................................................................................8

13. Reference ..............................................................................................................................8

14. Annexes ................................................................................................................................9

Annex 1: Customer complaints Receive form ..............................................................................9

Annex 2: Investigation of compliant form ................................................................................. 10

Disclaimer: This is a model standard operating procedure. It incorporates generic guidance

principles only. Firms are encouraged to adapt their own SOPs as necessary to suit their in-house
procedures.

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1. Background
Complaint is any written, electronic or oral communication that alleges deficiencies related to the
identity, quality, reliability, safety, effectiveness or performance of medical product. All
complaints and other information concerning potentially defective medicinal products must be
collected and reviewed. [This company] must maintain a record of all customer complaints
received relating to medicinal products. There should be a distinction made between complaints
about the quality of a medicinal product and those relating to distribution related matters.

2. Purpose
The purpose of this SOP is to describe effective and uniform compliant handling procedures
including initiation, review and reporting of quality related problems of medical product.

3. Scope
This SOP is applicable to compliant handling of quality defective medical product. For reported
incidents of safety and efficacy; [this Company] should use this SOP when an action is required
to protect public health.

4. Acronyms and Abbreviations

Nil

5. Definition

 Critical quality defects: Is potentially life threatening or could pose a serious risk to
patient which is categorized under Class I product recall guideline of EFMHACA.
 Major quality defects: are those which could cause illness or improper treatment but are
not critical, defect that could be categorized under Class II product recall guideline of
EFMHACA.
 Minor quality defects: are those which are unlikely to pose a risk to patient, Class III
recall guideline of EFMHACA

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6. Responsibility
6.1. It is the responsibility of the technical manager to receive complaints; conducting the
investigation and compile reports based on their investigation. The technical manager
should deliver a complete report to the compliant handling team (which composed of ware
house manager, sales man/promoters) and if necessary, appropriate follow-up action should
be taken after investigation and evaluation of the complaint.
6.2. Marketing department/Sales man are responsible to collect any written, electronic or oral
communication that alleges deficiencies related to the identity, quality, reliability, safety,
effectiveness of product and forwarding the complaints to the technical manager.

7. Materials and equipment

 Customer complaints receiving format
 Investigation of market compliant format

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8. Procedure flow chart

Receive compliant
(As shown Annex I)

Submit complaints to
Technical manager

Complaints investigated
(Annex II)

IS the
complai Close compliant
nt

CAPA (as per CAPA SOP)

Report to FMHACA

Feedback such as
temporary suspension or
complete withdrawals

Close compliant

Follow up

Documentation

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9. Procedure

9.1. Receive complaints in written or oral or electronic or any other form. Record the details of
the complaints from the originator in prescribed format (as shown in annexure I).
9.2. Receive the product from the customer, if any (as shown in annexure I)
9.3. Upon receipt of complaint, the Technical manager or Quality Assurance department or
assigned personnel should enter the complaint in the complaint register (as per the Annexure
2). The following details should be included;
 Serial Number
 Date of receipt
 Complaint Reference
 Complainant details
 Details of complaint (Product Name, Batch No., Quantity of sample & relevant
information as appropriate)
 Nature of Complaint (To be filled during investigation)
 Preventive Action (To be filled after investigation)
 Remarks: Reply Date (To be filled after investigation)
9.4. Review and evaluate all complaints to determine whether investigation is necessary
9.5. If investigation is required, after logging the complaints, the QA department or formed team
or any other responsible person has to start investigation of complaints (Annex II). Check
the condition of the stock and the stock card to confirm the lot no and expiration date and if
it is the same with the old stock. Besides, check the nature of complaint, verify the complaint
sample if any; and on the basis of initial investigation, then categorize the complaints into
critical/major /minor
9.6. During the investigation, include possible impact to other batches/units, the complaint
history for the particular batch/unit and a review of [the company] profile that could have
led to the complaint.
9.7. If investigation is not required, maintain records including the reasons why the investigation
was not done.

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9.8. Appropriate corrective and preventive actions should be documented and completed for
each confirmed complaint.
9.9. Prepare a reply based on the complete investigation.
9.10. Provide feedback to the customer or complainant. [the company] must write a response
letter to the complainant to explain the investigation approach, the results obtained and
any implications, in case the quality problem was confirmed.
9.11. When the corrective action has been completed, the conclusion should also be recorded
and Corrective Actions technical manager should sign off on the form and close the
complaint.
9.12. Follow up
9.13. Maintain all documentations and records

10. Document distribution

The SOP shall be distributed to:

 Technical manager office
 Warehouse manager office
 Sales man/promoter office

11. Records

11.1. After the completion of each activity, all documents and correspondence should be
recorded and filed in folder.
11.2. File numbers should be kept electronically and/or in hard copy for easy of tracing folders.
11.3. The change histories of this SOP should be kept and filed properly including all versions.
11.4. The different versions should be kept for _____years in traceable manner.

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12. Amendment histories

This SOP will be revised every two years or amended as appropriate.

Revision Number Summary of Changes Effective date
R0
R1
R2

13. Reference

 Food, Medicine and Healthcare Administration and Control Proclamation No. 661/2009.
[http://apps.who.int/medicinedocs/pdf/s4893e/s4893e.pdf. Accessed 28 Mar 2013];
 https://www.fda.gov/ICECI/Inspections/FieldManagementDirectives/UCM061481.
 Product Recall guideline (2015).1stedn. Available at:
(http://www.fmhaca.gov.et/documents/GDP,%20GSP%20and%20Recale%20Guideline
%202015.pdf)
 https://www.SOP for Handling of Market Complaints in Pharmaceuticals
Pharmaceutical Guidelines.htm
 https://www.fda.gov/downloads/MedicalDevices/InternationalPrograms/MDSAPPilot/U
CM379139.pdf

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14. Annexes

Annex 1: Customer complaints Receive form

Date:____________________

Complaint recorded by: ____________________

Complaint reported through Email, Fax, Oral, P.O box, other

Received from: _______________________________

Address: ____________________

Contact details: ________________

Product name, ________________

Strength _________

Pack size__________________________

Bache no.________ _Expiry date___________

Quantity_______________

Received by____________________ sign__________________

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Annex 2: Investigation of compliant form

Ref.no-------------------------- date of receipt----------------

Bach no--------
Product name-------------------- expired date ----------
Incidence----------------------------
Nature of compliant Critical/Major/Miner________________
Interpretation-------------
Scientific or practical reason_________________________________
Corrective action___________________________________________
Conclusion_________________________________________________
Technical manager (sign, Date)__________________________________

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Logo Document No: xxx
ORGANIZATION NAME
Approved date:
Effective date:
Title: Standard Operating Procedure for Return products Handling Revision No. 00 Page 1 of 6

Title: Standard Operating Procedure for Return products Handling Logo

Status: SOP No.

Prepared by Approved by Revised by Version No.

Name: Name Name Effective date:

Sig: Sig: Sig: Review date:

Date: Date: Date: Supersedes:

Table of Contents
1. Introduction .........................................................................................................................2

2. Purpose ................................................................................................................................2

3. Scope ...................................................................................................................................2

4. Responsibilities ....................................................................................................................2

5. Procedures ...........................................................................................................................3

6. Document distribution ..........................................................................................................4

7. Records ................................................................................................................................4

8. Amendment histories ...........................................................................................................4

Annexes ......................................................................................................................................5

Annex 1: Returned products Log .................................................................................................5

Annex 2: Returned product assessment form ...............................................................................5

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1. Introduction
It is essential to define the management of returned products that are sent back to the initial
distributors for any reason whatsoever. These returns must be carefully analyzed prior to any
salvaging, redistribution or disposal because products that have left the control of the warehouse
should only be returned to saleable stock if they are proven to meet the product’s appropriate
standards of safety, identity, strength, quality and purity.

This Standard Operating Procedure will describe the site’s roles and responsibilities and the order
of events for products returned from the market to the warehouse.

2. Purpose
The purpose of this standard operating procedure (SOP) is to describe the procedures for
handling of the returned products.

3. Scope
This SOP is applicable for handling of the returned products.

4. Responsibilities
 Sales/distribution manager is responsible to inform the technical and warehouse managers
about the returned product.
 Warehouse officer is responsible to identify the product returned, reconcile against
documents received and to verify the physical conditions of the received drug product
 Warehouse manager is responsible to manage, coordinate and assess the returned product
management
 Technical manager is responsible to conduct assessment on returned products and to decide
on disposition of those products
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5. Procedures
5.1. Sales/distribution manager receive notification on the returned product and pre-notify
warehouse manager and the technical manager before returned product arrive the warehouse.
5.2. While receiving returned product, warehouse officer shall identify the returned product batch
by name of the product, batch number, Expiry date against received documents and shall
check the following:
a. The specific reasons for the return product
b. Customer name & address who returned the product
c. Physical condition of all containers, and note the number of damaged containers and
inform warehouse manager
d. Quantity of shippers received and mentioned in returned document
e. Integrity of seal on each container/shipper
f. Storage condition of the material before returning the product.
g. Storage condition after product returned.
5.3. Warehouse manager receive and log in the returned product log book. Assign unique
sequential number for each returned product on the log book.
5.4. Identify all product as “Returned Good” with status label.
5.5. Move the product to the designated and secure Returned Good Storage area.
5.6. The warehouse manager and technical manager examine the assess the returned product.
This assessment should be recorded on the Returned Product Assessment Form (annex II).
The warehouse manager and technical manager formally decide on the disposition of the
product either return the product to saleable stock or reject the product.
5.7. The Warehouse manager shall update the Returned Medicinal Products Log (Annex 1) with
the disposition of the product.
5.8. If the product is rejected warehouse officer shall transfer to the ‘reject area’ and recorded in
Rejected Products Log.
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5.9. If the product is returned to saleable stock warehouse officer shall transfer the product
saleable stock area and enter onto the inventory management system.

6. Document distribution

This SOP shall be distributed to:

 Technical manager office
 Warehouse manager office
 Sales/distribution manager

7. Records
1.1. After the completion of each activity, all documents and correspondence should be
recorded and filed in folder.
1.2. File numbers should be kept electronically and/or in hard copy for easy of tracing folders.
1.3. The change histories of this SOP should be kept and filed properly including all versions.
1.4. The different versions should be kept for _____years in traceable manner.
8. Amendment histories
This SOP will be revised every two years or amended as appropriate.
Revision Number Summary of Changes Effective date
R0
R1
R2
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Annexes

Annex 1: Returned products Log

Date of Name of B.no Exp. Quantity Returned Reason for Condition of Dispositio Checked
product the Date by return the product n details by
returned product (S/R)*

* S (Saleable stock), R (Reject)

Annex 2: Returned product assessment form

Date Product name Product Batch no. Expiry date Quantity
strength

Returned from: ______________________________________________________________

Reason: ____________________________________________________________________

Date of original delivery to customer: ____________________________________________

(must be within 10 days of receipt of return)

Description of the condition Response

Acceptable shelf-life remaining? Yes No
Products in original unopened pack? Yes No
Products in good condition? Yes No
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Evidence that the product was transported, Yes No

stored and handled under proper
conditions?
Evidence that the product was originally Yes No
supplied to the customer from the company
(e.g. copy of delivery note attached)?
Reason to believe that product is / has been Yes No
falsified?

Product assessed by: _________________________________Date: __________________

Disposition________________________________________________________________

(Return to Saleable Stock or Reject)

Approved by: _____________________________(RP) Date: ________________________

Logo Document No: xxx
ORGANIZATION NAME
Approved date:
Effective date:
Title: Standard Operating Procedure for Recall Handling Revision No. 00 Page 1 of 10

Title: Standard Operating Procedure for Recall Handling Logo

Status: SOP No.

Prepared by Approved by Revised by Version No.

Name: Name Name Effective date:

Sig: Sig: Sig: Review date:

Date: Date: Date: Supersedes:

Table of Contents
1. Introduction .........................................................................................................................2
2. Purpose ................................................................................................................................2
3. Scope ...................................................................................................................................2
4. Responsibilities ....................................................................................................................2
5. Procedure .............................................................................................................................2
6. Reference to other documents ..............................................................................................5
7. Document distribution ..........................................................................................................5
8. Records ................................................................................................................................5
9. Amendment histories ...........................................................................................................6
Annexe........................................................................................................................................6
Annex 1: Pharmaceutical product recall log.................................................................................6
Annex 2: Pharmaceutical product recall record............................................................................7

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1. Introduction
Product recall is indicated when a product distributed could represent a hazard to the consumer.
During this event recall program will effectively remove products from circulation. All products
distributed have production dates, expiry dates, and batch number attached to them. In the event
of a problem with any product, contacting all customers who received the product by letters, phone
fax or any means of communication to recall the products.

In the case of a serious health hazard, a public warning via the media, either on a local or regional
basis to ensure the public safety should be released.

2. Purpose
The purpose of this SOP id to establish the procedure for prompt and efficient recall of products
known or suspected to be defective, from the market.
3. Scope
This SOP applies to all types of recalls either initiated by [XXX company] by its initiative or by
the Ethiopian Food, Medicine and Healthcare Administration and Control Authority
(EFMHACA).
4. Responsibilities
 It is the responsibility of the Technical Manager/responsible person to notify the
product recall to the regulatory authority and to other relevant organizations.
 The designated responsible person/Technical manager shall ensure that product
recall can be executed effectively and promptly upon receiving the recall instruction
from the Managing Director or recall order from any regulatory authority.

5. Procedure

5.1. Recall can be initiated in the following situations:

a. A recall instruction decision from the Managing Director in response to a complaint
received, where serious product quality problem was detected in product and/or product
was found to have potentially caused adverse reactions in consumers;

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b. A recall instruction decision from the Managing Director in response to any in-house
detected defective products;
c. A recall order from any Regulatory Authority including EFMHACA
5.2. Recalls are classified into the following categories:
Class 1 Recall

Initiated when the product defect poses a life-threatening situation to users or could cause a serious
risk to health. Some examples of defects that will result in Class 1 recall are contamination with
toxic substances and products with major labelling errors. Such recalls shall be notified licensee’s
clients with highest urgency and reported to EFMHACA immediately (within 24 hours).

Class 2 Recall

Initiated when the problem or defect could result in illness or improper treatment, but the
consequences unlikely to cause serious harm to users as in class 1 recall. Some examples of defects
that will result in Class 2 recall include products with minor labelling errors or products which fail
to meet product specification or pharmacopoeia standards but are likely to cause minimal hazard
to users.

Class 3 Recall

Initiated when there is a situation in which the product to be recalled contains defects that may not
pose a significant hazard to health. Example: labelling violations.

5.3. The designated responsible person/Technical manager shall inform the sales/marketing
department or inventory control section to generate the distribution records of the affected
batch. The information should include: name product, batch number, manufacturing & expiry
dates, the quantity to be recalled and the areas of were the product was distributed.
5.4. All sales of defective products will be ceased immediately and the designated responsible
person/technical manager shall instruct the storekeeper to immediately remove any balanced

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stock of the affected batch from the warehouse and quarantine the goods at designated
quarantine area.
5.5. All recipients of the affected product shall be notified the nature of the recall by telephone.
For end-user recall, means of appropriate mass media communication should be considered.
5.6. A recall letter will be prepared by the designated responsible person/technical manager to be
sent to all recipients of the affected batch listed in the distribution record to inform them that
recall operation is activated, and to stop selling and remove the affected product from the
racks with immediate effect
5.7. The designated responsible person/technical manager shall notify EFMHACA for which the
affected product batch is exported should be notified of the recall in situations 1.1 and 1.2.
Report must be made to the Authority within 24 hours from the receipt of the defective
reports.
5.8. The designated responsible person/technical manager shall instruct the delivery personnel to
collect the recalled product back from the market, the pharmacies, hospitals, distributors or
any other outlets as stated in the distribution record.
5.9. The warehouse manager shall clearly identify and store all recalled goods collected from the
market in the designated secure area while awaiting management’s decision or the
Authority’s instruction on their fate.
5.10. The designated responsible person/technical manager shall record the progress of the recall
process and issue the final report, including a reconciliation between the delivered and
recovered quantities of the products.
5.11. The designated responsible person/technical manager should file the records in the Recall
file kept. Detail of the product should be written in pharmaceutical product recall log
(appendix 1) and pharmaceutical recall log (appendix 2).
5.12. The designated responsible person/technical manager shall carry out a mock recall on a
yearly basis to assess the effectiveness recall system put in place. Any gaps found in the

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system during the mock recall shall be appropriately addressed so that operation can be
activated immediately and promptly during an actual recall.
6. Reference to other documents
 Product Recall Form (FORM-XXX)
7. Document distribution
The SOP shall be distributed to:
 Technical manager office
 Warehouse manager office
 Sales/distribution office

8. Records
1.1. After the completion of each activity, all documents and correspondence should be
recorded and filed in folder.
1.2. File numbers should be kept electronically and/or in hard copy for easy of tracing folders.
1.3. The change histories of this SOP should be kept and filed properly including all versions.
1.4. The different versions should be kept for _____years in traceable manner.

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Effective date:
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9. Amendment histories
This SOP will be revised every two years or amended as appropriate.
Revision Number Summary of Changes Effective date
R0
R1
R2

Annexe
Annex 1: Pharmaceutical product recall log
Notification Product Product Dosage Batch Expiry Product Date Entry by
receipt date name strength form no(s) date distributed recall
(Y/N) closed

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Annex 2: Pharmaceutical product recall record

I. Details of the Recall

Product name

Product strength

Product form (e.g. tablets, sachets, powder)

Product packaging (e.g. tablets in a tub, blisters

in a carton)
Batch no(s)

Expiry date

PA number

Name of the marketing authorisation holder

Reason for recall

Classification of recall

Level of recall (e.g. to wholesale level, to retail

level, to consumer level)
Supplier details

Total quantity received from supplier for each

batch
Total quantity distributed for each batch

Cause of the quality defect

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(Note this only applies if the recall action was

taken as a result of an error that occurred at the
company)
Specific corrective actions to be implemented
by the company addressing the issue which led
to the recall
(Note this only applies if the recall action was
taken as a result of an error that occurred at the
company)
Section I completed by:

Date:

II. Results of the Recall – Reconciliation

(a) Number of packs of recalled product

received from supplie

(b) Number of packs of recalled product in

stock

c) Number of packs of recalled product

distributed

(d) Number of packs of recalled product

received back from customers

(e) Number of packs of recalled product not

returned

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Percentage of packs reconciled (i.e. number of

packs received back as a % of the number of
packs distributed)

(d) / (c) x 100

Unaccounted stock

(b) – {(a)– (c)}

Section II completed by: Date:

III. Chronological Account of the Recall

Date quality defect identified

Date quality defect reported to

supplier/EFMHACA

Date of approval of recall notification by the

EFMHACA

Date recall notification received

Date of quarantining of stock held

Dates within which recalled packs were

received back from customers

Dates within which recalled packs received

back from customers was quarantined

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Date of sending Recall Report to the

supplier/manufacturer/EFMHACA

Section III completed by: Date:

Report reviewed by (RP):_______________________Date:________________________

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Title: Standard Operating Procedure for Medicine Waste Handling Revision No. 00 Page 1 of 10
and Disposal

Title: Standard Operating Procedure for Medicine Waste Handling and Disposal Logo

Status: SOP No .
Prepared by Approved by Revised by Version No.

Name: Name Name Effective date:

Sig: Sig: Sig: Review date:

Date: Date: Date: Supersedes:

Disclaimer: This is a model standard operating procedure. It incorporates generic guidance principles
only. Firms are encouraged to adapt their own SOPs as necessary to suit their in-house procedures.

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and Disposal

Table of Contents
1. Introduction ...................................................................................................................................... 3
2. Purpose ............................................................................................................................................. 3
3. Scope ................................................................................................................................................. 3
4. Acronyms ......................................................................................................................................... 3
5. Definition .......................................................................................................................................... 3
6. Responsibilities ................................................................................................................................ 5
7. Materials and Equipment ................................................................................................................. 5
8. Procedures ........................................................................................................................................ 6
9. Distribution ....................................................................................................................................... 7
10. Records............................................................................................................................................ 7
11. Revision History ............................................................................................................................. 8
12. References ....................................................................................................................................... 8
13. Annexes........................................................................................................................................... 9

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1. Introduction

Medical products may arrive past or near their expiry date, may be inappropriate for the needs,
become unfit for use or may be damaged because of unforeseen reasons. Segregation of unfit for
use medical products from usable medical products and disposing them at regular intervals in
environmentally friendly disposal firm or area is one of the principles that must be followed.

2. Purpose
This Standard Operating Procedure (SOP) is to detail the good practice of safe and appropriate
handling and disposal of medicine waste in compliance with current national legislative
requirements.

3. Scope
This SOP applies to safe and appropriate medicine waste handling and disposal.

4. Acronyms
Nill

5. Definition

a) Biodegradable means a type of waste, typically originating from plant or animal sources,
which may be degraded by other living organisms.
b) Central disposal site means a site established and operated by appropriate organ which
provides medicines waste management and disposal services.
c) Disposal Firm means any waste Management Company licensed to dispose medicines
waste. It can be a medicines importer, wholesaler, distributor, manufacturer or any private
or public business authorized to dispose medicines wastes for fee.
d) Disposal Referral System means a system to pass on medicines wastes to a licensed
disposal firm, medicines supplier, manufacturer or central disposal site for disposal services
for fee.
e) Hazardous Substance means a waste that poses substantial or potential threats to public
health or the environment ignitability, reactivity, corrosiveness and toxicity.
f) High Temperature Incinerator means an incinerator that generates at least 1200°C in the
secondary chamber, and is fitted with gas cleaning equipment.

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g) Highly Engineered Sanitary Landfill means an engineered landfill with landfill gas
extraction, groundwater monitoring and leachate treatment facilities and monitored by
trained staff
h) Medicine waste means waste which encompass the following:
 All properly unsealed bulk products or loose tablets and capsules. If unexpired these
shall only be used when the container is still sealed, properly labeled or still within
the original unbroken blister packs,
 All cold chain damaged, unexpired medicines that should have been stored in a cold
chain but were not,
 Counterfeit, substandard and adulterated,
 Discarded items used in the handling of medicines,
 Expired, unused, spilt, and contaminated,
 Improperly sealed or labeled or stored,
 Expired, damaged, and improperly sealed or labeled or stored laboratory reagents,
 Expired, damaged, and improperly sealed or stored medical supplies;
 Prohibited or unauthorized medicines,
 Expired, damaged, and improperly sealed or labeled or stored raw materials, and
 Discarded packing materials.
i) Medium Temperature Incinerator means a two-chamber incinerator with minimum
temperature of 850oC.
j) Open Controlled landfill means a landfill where medicines waste is covered with large
amount of municipal wastes but it is still left open.
k) Open uncontrolled landfill means a landfill where medicines waste is not covered with
large amount of municipal wastes and it is left open.
l) Sewer means a flushing of medicines wastes to the sewerage system after proper dilution
and regulation.
m) Waste Inertization means a variant of encapsulation and involves removing the packaging
materials including blister packs, paper, cardboard and plastic from the medicines and then
crushing and mixing medicines with cement, lime and water.

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n) Waste Encapsulation means a landfill approach to reduce the risk of medicine waste
through immobilizing the medicine in a solid block within a plastic or steel.

6. Responsibilities

Title Responsibility
Storage and Distribution Head/  Verify proper segregation of unfit for use item from
Warehouse manager usable items.
 Ensure placement of unfit for use item in designated
quarantine room.
 Confirm retention of medicine waste records
 Ensure timely and proper disposal of medicine waste
in-line with national regulatory authority procedure.
Warehouse personnel  Timely segregation of unfit for use products from
usable items
 Placement medicine waste in secure quarantine room
 Maintenance of medicine waste record before
placement to quarantine room.
 Ensure timely disposal medicine waste in-line with
national authority procedure.
Technical Manager  Verify proper and timely disposal of quarantined
medicine waste.
 Ensure placement of medicine waste in safe and
secure quarantine room

7. Materials and Equipment

 Personal protective equipment such as gown, glove, face masks, boots etc
 Stationary materials
 Appropriate disposal equipment

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8. Procedures

8.1. Check the presence of unfit for use medical products such as expired, damaged, returned
products by looking on bin cards or other stock controlling mechanisms such as electronic
data base and confirm the stock present in the warehouse. Investigate when there is
discrepancy.
8.2. Separate unfit for use medicines from useable stocks including expired, damaged and
returned products in to designated quarantine room.
8.3. Record each medicine waste on the register book and compile appropriately, made ready for
regulatory inspection as per annexed format (Annex II).
8.4. Establish a disposal team consisting of supervising pharmacists, store house keepers, who
are experienced pharmaceutical warehouse personnel.
8.5. Sorting out of each pharmaceutical from stockpiles into separate categories for which
different disposal methods are required. Sorting is done in the open or in a well-ventilated
area as close as possible to the stockpile in an orderly way, with all sorted material clearly
labelled and separated at all times.
8.6. Supply staffs with protective equipment (gown, gloves, boots, dust masks, etc.), and works
under the direct supervision of a pharmacist.
8.7. Train disposal team on sorting criteria, and health and safety risks associated with handling
wastes.
8.8. The first step in dealing with stockpiles is to remove and dispose of non-drug, non-chemical
items. All such items should be clearly separated from pharmaceuticals and chemicals.
8.9. For those to be disposed a decision is made on the best method of disposal. The
pharmaceuticals to be disposed should be separated from their packaging at disposal site.
8.10. The remaining unwanted pharmaceuticals that should never be used and considered
pharmaceutical waste must be:
a. Sorted by active ingredients
- Controlled substances; e.g. narcotics, psychotropic substances
- Anti-infective drugs
- Antineoplastic
- Antiseptics and disinfectants etc.

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b. Sorted by dosage form:

- Solids, semi-solids and powders such as tablets, capsules, granules, powders for
injection, mixtures, creams, lotions, gels, suppositories, etc.;
- Liquids such as solutions, suspensions, syrups, etc.; and ampoules;
- Aerosol canisters such as propellant driven sprays and inhalers.
8.11. Once sorted, the pharmaceuticals wastes should be carefully packed into steel drums or into
containers such as sturdy cardboard boxes, with the contents clearly indicated on the
outside of the containers.
8.12. Label containers containing sorted medicines waste and kept in a dry, secure and preferably
a separate room.
8.13. Submit recorded medicine waste along with application letter as per annex II and III and
communicate with appropriate regulatory body ahead of disposal date.
8.14. Disposal site is selected in agreement with appropriate regulatory body considering
Environmental Impact Assessment
8.15. Transporting of sorted medicines waste to agreed disposal sites in closed motor vehicles to
avoid pilferage.
8.16. Dispose sorted medicines with appropriate disposal method in the presence of EFMHACA
inspectors as per national disposal legislatives.
8.17. Formal request of Disposal Certificate from the Authority and document disposal
certificate for regulatory purpose and show to inspectors when requested.

9. Distribution
This SOP distributed to:
- Original copy kept in quality assurance department/general managing/ technical manager
- Warehouse manger

10. Records
1. After the completion of each activity, all documents and correspondence should be
recorded and filed in folder.
2. File numbers should be kept electronically and/or in hard copy for easy of tracing folders.

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Logo Document No: xxx
ORGANIZATION NAME Approved date:
Effective date:
Title: Standard Operating Procedure for Medicine Waste Handling Revision No. 00 Page 8 of 10
and Disposal

3. The change histories of this SOP should be kept and filed properly including all versions.
4. The different versions should be kept for _____years in traceable manner.

11. Revision History

Revision number Summary of change Effective date

R0 New SOP To be assigned
R1
R2
R3

12. References
1. Food, Medicine and Healthcare Administration and Control Authority of Ethiopia፡
Medicines Waste Management and Disposal Directive, 2011
2. World Health Organization: Guidelines for safe disposal of unwanted pharmaceuticals

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Logo Document No: xxx
ORGANIZATION NAME Approved date:
Effective date:
Title: Standard Operating Procedure for Medicine Waste Handling Revision No. 00 Page 9 of 10
and Disposal

13. Annexes
Annex I: Summary of Disposal Methods

Category Disposal methods Comments

Solids Landfill
Semi-solids Waste encapsulation
Powders Waste inertization
Medium and high temperature
incineration (cement kiln incinerator)
Liquids Sewer Antineoplastics shall not be
disposed in sewer.
High temperature incineration (cement
kiln incinerator)

Ampoules Crush ampoules and flush diluted fluid Antineoplastics shall not be disposed
to sewer in sewer.
Anti-infective Waste encapsulation Waste inertization Liquid antibiotics may be
medicines Medium and high temperature diluted with water, left to
incineration (cement kiln incinerator) stand for several weeks and
discharged to sewer.
Antineoplastics Return to supplier, manufacturer or Donor, Antineoplastics shall not be disposed
into landfill unless
Waste encapsulation, encapsulated, and shall not be
Waste inertization, disposed by sewer or by medium
High temperature incineration temperature incineration.
(cement kiln incinerator)

Shall not be disposed into Landfill

Controlled unless immobilized.
Waste encapsulation
substances
Waste inertization
Medium and high temperature
Incineration (cement kiln incinerator)

Aerosol
Landfill, waste encapsulation Not to be burnt: may explode.
canisters
Disinfectants To sewer: small quantities of diluted No undiluted disinfectants shall be
disinfectants (max. of 50 liters per day disposed to sewer.
under supervision)
PVC plastic, Landfill Shall not be disposed by burning.
Glass
Paper, Recycle, burn or landfill
cardboard
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Logo Document No: xxx
ORGANIZATION NAME Approved date:
Effective date:
Title: Standard Operating Procedure for Medicine Waste Handling Revision No. 00 Page 10 of 10
and Disposal

Annex II: Medicines Waste Register Book

S.no Description of Unit Quantity Batch Expired Reason for Manufacturer/ Store Purchase
Medicines Wastes Type numbe date Disposal Supplier location Value
(generic & brand and r (expired,
name, strength and Size damaged,
dosage form) spilled, etc)

Annex III: Medicines Waste Disposal Application Form

To: Appropriate Organ (when the applicant has its own disposal facility)
Subject: Request for Medicines Waste Disposal

I/We ------------------------------of (address) --------------------------undertaking the business of

(specify) ------------------------------------------------- hereby apply for disposal of medicines waste.
License Number-----------------------------issued on-----------------------
Location of Business---------------------------------------------------------------
Name of person in charge -----------------------------------------------------
Reason for disposal----------------------------------------------------------------------------
Weight (in Kg) ----------------------------------------------------------------------------------
Value (in Birr) ----------------------------
Attached herewith is the list of products to be disposed
Declaration
I certify that the information provided in the application form is true and correct.
Date of application--------------------------------- Signature of Applicant--------------------------------
--------------------Stamp----------------------------------------------------------

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Logo Document No: xxx
ORGANIZATION NAME Approved date:
Effective date:
Title: Standard Operating Procedure for Security Revision No. 00 Page 1 of 4

Title: Standard Operating Procedure for Security Logo

Status: SOP No.

Prepared by Approved by Revised by Version No.

Name: Name Name Effective date:

Sig: Sig: Sig: Review date:

Date: Date: Date: Supersedes:

Table of Contents
1. Introduction .........................................................................................................................2

2. Purpose ................................................................................................................................2

3. Scope ...................................................................................................................................2

4. Responsibility ......................................................................................................................2

5. Procedures ...........................................................................................................................3

6. Distribution ..........................................................................................................................4

7. Records ................................................................................................................................4

8. Revision History ..................................................................................................................4

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Logo Document No: xxx
ORGANIZATION NAME Approved date:
Effective date:
Title: Standard Operating Procedure for Security Revision No. 00 Page 2 of 4

1. Introduction
There are different critical barriers that adversely impact supply chain operations such as theft
during storage, distribution and transportation. Well-functioning pharmaceutical supply chains
system that will effectively deliver medicines to the end user is very important. This can be ensured
by developing and implementing security procedures to assure the availability of quality and
effective medical products.

2. Purpose
The purpose of this SOP is to detail the procedures for mitigating security risks to the supply
chain, such as theft during storage, distribution and transportation processes.

3. Scope
This SOP is applied on organization engaged in storage, distribution and transportation of
pharmaceutical products.

4. Responsibility
4.1 The security guards are responsible to:
 Ask security badge to approve someone to be on site
 Ensure adequate lighting inside and outside the facility
 Check the pharmaceutical products to be transported before delivery

4.2 The store managers are responsible to:

 Aware of the procedures to address a situation and how to report it
 Assure fire suppression and alarm systems are secured, monitored.
 Receive and dispatch medical products as per receiving and dispatching SOPS.
 Assure warehouse integrity by periodic inspection.
 Maintain all necessary records.

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ORGANIZATION NAME Approved date:
Effective date:
Title: Standard Operating Procedure for Security Revision No. 00 Page 3 of 4

4.3 The technical manager or other responsible body is responsible to:

 Develop the Security Plan
 Verify the works of the store manger
 Maintained all necessary records for reasonable period of time
 Use monitoring systems to prevent unauthorized access to storage areas and during
transportation as needed.
 Designate appropriate staff as security personnel as needed.
 Provide specific training in maintaining integrity and protecting access controls in
storage area in warehouse and during transportation.
 Develop security management system integrated with the quality management system

4.4 The driver is responsible to:

 Assure all pharmaceutical products in delivery are distributed without any theft.

5. Procedures
5.1. Develop the Security Plan
5.2. Designate appropriate staff as security personnel as needed.
5.3. Provide specific training in maintaining supply chain integrity and protecting access
controls in storage area in warehouse and during transportation.
5.4. Use monitoring systems to prevent unauthorized access to storage areas and during
transportation as needed.
5.5. Maintained all necessary records for reasonable period
5.6. Develop security management system integrated with the quality management system
5.7. Aware of the procedures to address a situation and how to report it
5.8. Assure fire suppression and alarm systems are secured, monitored and maintain necessary
all records.
5.9. Receive and dispatch pharmaceutical products as per receiving and dispatching SOPS.

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Logo Document No: xxx
ORGANIZATION NAME Approved date:
Effective date:
Title: Standard Operating Procedure for Security Revision No. 00 Page 4 of 4

5.10. Assure warehouse integrity by periodic inspection and maintain all necessary records
5.11. Ask security badge to approve someone to be on site
5.12. Ensure adequate lighting inside and outside the facility
5.13. Check the Pharmaceutical products to be transported before and after delivery to assure
any theft
6. Distribution
This document is distributed to

 Technical managing office

 Warehouse manager
 Security guards
 Deliver/Drivers

7. Records
1. After the completion of each activity, all documents and correspondence should be
recorded and filed in folder.
2. File numbers should be kept electronically and/or in hard copy for easy of tracing folders.
3. The change histories of this SOP should be kept and filed properly including all versions.
4. The different versions should be kept for _____years in traceable manner.
8. Revision History

Revision number Summary of change Effective date

R0
R1
R2
R3