AUDIT OF WAREHOUSE AND

WEIGHING

Presented By – Gayatri H. Tiwaskar

M.Pharm 1st (2nd sem) (PQA)
Guided By – Mrs. Shilpa Pise mam
Dadasaheb Balpande College of Pharmacy,Besa,Nagpur-34
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 CONTENT
• Audit
• Warehouse
-Objective
-Ideal Warehouse
-Checklist
• Weighing
-Checklist
• Reference
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 What is an audit ?
Quality audit is the process of systematic
examination of a quality system carried out by an
internal or external auditor or an audit team.

Types:
1. Internal Audit
2. External Audit
3. Regulatory Audit

Auditor : A person who has appropriate qualifications and perform audit.

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04/16/2020 4
 What is a warehouse?

Place where goods are kept is called –WAREHOUSE

Warehousing is a set of activities that are involved in

receiving and storing of goods and preparing them for
Reshipment.

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 Receipt of products from
1
Manufacturing plant.
Transfer into the
2 warehouse.

Placement at designated
3 place
4 Regrouping products

Transferring on transport Storing products in the

5 vehicle.
6 warehouse till delivery to
ultimate consumer.

Warehousing process of finished goods

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 Objectives
To assess whether processes and controls are sufficient to
support effective and efficient warehouse management.

Effective: Producing a result

that is wanted.

Efficient: Capable of producing

desired results without wasting
materials, time, or energy.

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 Ideal Warehouse
• The warehouse should be of sufficient size to allow
handling and storage of products in a manner that does
not result in product contamination.
• The warehouse should be properly ventilated to prevent
condensation.
• Openings leading to exterior should be meshed to prevent
the entry of pests.
• Floors should be non-slipy, evenly graded to prevent
water stagnation.

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• Floors are to be constructed using impervious, non-
toxic, non-absorbent and crack resistant materials
• Stocks are rotated according to the
First In First Out - FIFO system
First Expire First Out - FEFO system and adequate
records for the system must be kept.

• Good housekeeping practices should be observed at

all times.

• Eating, drinking, smoking, chewing of gum or

tobacco, littering and other undesirable behaviour at
designated areas in the premises is prohibited.
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• Any person who has or appears to have an infectious
disease, open lesion, including boils, sores, or infected
wounds, or any other abnormal source of microbial
contamination must be excluded from any operations.

• There should be pest management practices in place to

prevent the harborage and breeding of pests on the
grounds and within the warehouse facility.

• No pets including birds and animals are to be kept within

or around the warehouse premises.

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• The personnel working in the warehouse should be
properly gowned.

• Adequate lightings - to permit effective cleaning and to

ensure that the storage operations can be carried out in a
hygienic manner.

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04/16/2020 12
 Checklist for Audit

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 RECEIVING
RECEIVING
•Are warehouse operating procedures current and on file?
•Are receiving documents available at time shipment is received?
•Are they adequate for complete identification of material in the
shipment?
•If not, is the fact reported so corrective action may be taken?
•Are items checked for description, quantity and condition at the
arrival of shipment?
•Are receiving reports being processed properly?
•Is management informed of any abnormal backlogs of unprocessed
receiving reports?
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 PRODUCT/
INVENTORY/ORDERS

•Are spot checks conducted to determine the location of the material

as reflected on the stock records?
•Are the stock records reflecting shelf-life information retained in a
follow-up file?
•Are the inspectors notified when shelf-life items are scheduled for
re-inspection?
•Are periodic spot checks conducted to verify the quantity and
condition of material indicated on the stock records?

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•Is the proper procedure being used when discrepancies exist?
•Is material in storage reviewed periodically to determine the
necessity for reprocessing?
•Are orders received in sufficient detail to readily identify the
material that is to be withdrawn?
•Does a backlog of orders exist? If so, is management informed of
the fact?

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 SHIPPING

• Is any action taken to reconcile a shipment with the order?

• Are outbound shipments properly manifested?
• Are carriers promptly billed at the completion of loading?
• Are carrier tariffs being observed?
• What percentage of orders meets the promised delivery date?

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 STORING

•Are storage methods best suited to the characteristics of the

storage areas?
•Does the storage plan permit flexibility of operations and provide
for adequate small-lot storage space?
•Are stored materials adequately and accurately marked for proper
identification and easily located through use of the locator file?
•Are materials of similar categories grouped together as much as
practicable?

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• Are hazardous and flammable materials stored separately?

• Are materials stacked correctly to ensure the greatest safety to

personnel, protection of material and accessibility?

•Are all materials that are not palletized raised off the floor by use
of dunnage?
•Are open or damaged cases of cartons removed from stacks and
repacked?
•Are packing, crating and other preparations for shipment
adequate?

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•Are items generally properly packaged and processed prior to
receipt?
•Is an adequate inspection made of the condition of incoming
items?
•Are adequate and proper steps taken to care and preserve storage
items?

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MATERIAL HANDLING EQUIPMENT (MHE)

•Is MHE utilized to the maximum?

•Is MHE adequate for a balanced operation?
•Is inadequate maintenance of equipment interfering with
operations?
•Could operations be made more efficient by exchanging one type
and size of equipment for another?
•Is MHE centrally controlled and properly distributed for
maximum utilization?

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•Is an adequate checkout system in operation governing use of
MHE?
•Is available MHE the proper size and type for efficient handling
of items in storage?

•Are additional or different types of equipment needed?

•If so, have specific requirements been reported?
•Is all equipment maintained in good operating condition?

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•Are routine adjustments and minor repairs made promptly?
•Are preventative maintenance inspections and lubrication made
on each MHE item?
•Is MHE being misused?
•Are thorough periodic checkups made of all motorized
equipment?
•Has any equipment been out of operation for an abnormal period
of time ? Are such cases reported?
•Are MHE records maintained so information is readily available
to meet inventory and accounting requirements?

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WAREHOUSE LAYOUT

•Is a diagrammatic plan of the warehouse layout available and in use?

•Is it used to pre plan storage space?
•Are closed and open storage areas designated on the plan and clearly
marked?
•Is maximum storage space being utilized considering type of
commodities, cube, floor load capacity, aisle space and accessibility?
•Is space used for non-storage activities kept to a minimum?
•loading and unloading, "in and out checking," and moving materials
can be done efficiently ?
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• Is aisle accessibility for inspection and withdrawals being carried
to an extreme?
• Is repeated re warehousing necessary due to excessive
honeycombing?
• Are sufficient pallets on hand?
• Are they of proper type and size?
• Are excess pallets reported as available for use elsewhere?
• Are receiving and shipping bays located and sized so that loading
and unloading, "in and out checking," and moving materials can be
done efficiently ?

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HOUSEKEEPING

•Are structures and grounds properly maintained? By whom?

•Are periodic inspections made of the storage facility to determine

any major repairs or construction needed to protect the real property
from abnormal depreciation?

•Are reports made to management of any overtaxing of existing

facilities that may require additional construction, repairs or possible
change in operating procedure?

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•Are floors swept, stacks even, and general maintenance performed?
•Are toilets, washrooms and locker rooms maintained in a neat and
sanitary condition?

ACCIDENT PREVENTION

•Are all accidents fully investigated, analyzed and reported

promptly and accurately?
•Are causes of accidents corrected immediately?
•Are first aid facilities adequately provided?
•Are trained first-aid personnel available at the facility?

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GUARD SERVICE
•Is guard service adequate for proper protection of real and
personal property?
•Does your contract alarm service provide responsive protection?
•Have you tested their alarm service yourself?

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FIRE PROTECTION

•Is all fire fighting equipment conspicuously marked and readily

accessible?
•Are fire extinguishers, sprinkler systems and other protective
equipment inspected periodically and a record kept of the inspection
dates?
•Have personnel been instructed about the location and use of
available equipment as well as the method of notifying the local fire
department when necessary?
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•Are scheduled inspections of the premises made to eliminate fire
hazards and enforce precautionary measures?
•Is the proper type of fire protection available?

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SAFETY
•Is there a safety and accident prevention program in effect?
•Does management take an active interest and participate ?
•Are combustible and flammable materials segregated from other
materials?
•Are supervisory personnel safety conscious and do they understand
safety and accident prevention methods?
•What is the attitude of employees to safety enforcement?

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•Is there a job training program in effect?
•If so, are employees instructed in the use of safety methods on their
particular jobs and what they are to do in an emergency?
•Are "no smoking," "no trespassing" and other safety signs
adequately displayed?

•Are safety devices provided and do personnel use protective

clothing?
•Have safety guards or other safety devices been removed or
rendered ineffective?

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•Are proper safety measures taken when operating all materials
handling equipment?
•Are preventive maintenance operations effective?
•Are safety methods strictly enforced in handling and storing materials
and in housekeeping practices?
•Are special safety measures used in the care and handling of all
hazardous materials?

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PERSONNEL
•Are personnel qualified to perform their assigned functions?
•Have administrative personnel received training in correct preparation
of forms, reports and other clerical duties?
•Are there any labour and/or management problems?
•Is there an accurate timekeeping record of labour hours?
•Are time and attendance records accurate and properly maintained?

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•Has the use of sick and annual leave been explained to employees?

•Are there too many or too few employees in relation to the average
warehousing operational workload?

•Are seasonal workloads a factor?

•high low Is employee morale high? Low? Give the reasons.

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SUPERVISION
•Do supervisors properly plan and schedule work?

•Are daily conferences held with key operating personnel to discuss

warehouse problems and overall planning of warehousing activities?

•Are weekly conferences held with key operating personnel to

discuss warehousing problems and overall planning of warehousing

activities?

•Is warehouse labour used to the best advantage?

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•Are crews balanced?

•Are warehouse supervisors, checkers, materials handling

equipment operators and other personnel adequately trained for

their particular job? .

•Are periodic checks made by supervisory personnel to see if there

is idling or lagging on the job?

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 Summary

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 WEIGHING
Weighing means - To find out how heavy the material (to be
weighed is) by typically using scales.

For Non Sterile

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For Sterile 39
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 CHECKLIST
• Is the area equipped to avoid cross-contamination and
physically separated from the other rooms by walls or other
type of separation?

• Are lighting and ventilation adequate?

• Is there temperature and humidity control, where required?

• Are weighing and dispensing area maintained in a clean

condition?
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•Is there proper supervision in the area?
•Have the personnel received GMP training?
•Do the personnel receive up-dated training?
•Are personnel wearing appropriate clothing?
•Is protective clothing (gloves, caps, masks etc.) used during the
weighing operations?
•Are the utensils used for weighing (receptacles, scales, hoppers,
spatulas, pipettes etc.) properly cleaned after each use?

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•Are these utensils kept in an appropriate place which is free from
contamination?
•Are the scales and balances used for weighing calibrated
regularly?
•Are these recorded?

•Are records for these calibrations maintained?

•Are the containers of the raw materials to be weighed cleaned
before being opened?

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•After weighing, are these containers well sealed?
•Are raw materials or components for each batch properly identified
and segregated after weighing?

Does this Identification Include:

a) The name of the raw materials or component?
b) The batch and another control number of the raw material or
component?
c) The batch number of the drug product to be manufactured?
d) The quantity that was weighed?

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• Are there written procedures for handling, weighing, counting
and dispensing a raw materials and packaging materials?
• Are only the relevant raw materials, intermediate products and
bulk products located within the dispensing area?
• After weighing, dispensing and labeling, are raw materials,
intermediate products and bulk products transported and stored
in a manner that will preserve its integrity until further
processing?

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• Prior to weighing and dispensing, is each container of raw
materials checked for proper labeling, including the approval
label from quality control?.
• Are capacity, accuracy and precision of weighing and
measuring equipment used appropriately to the number of
materials to be weighed or measured?

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 REFERENCES

•https://en.wikipedia.org/wiki/Auditor (06-03-18, 21:58)

•Quality Assurance audits in pharma industries, Rasika Walunj, Morden college of
pharmacy, moshi slideshare (slide no:7-11)(06-03-2018;22:36)
•https://www.slideshare.net/Dolita-Shah/quality-audit (slide no:16) (06-03-
2018;22:46)
•http://www.warehousingforum.com/news/2003_08.pdf , volume 18, number 9,
2003(Reasons to audit ; 21-02-18,23:08)
•https://blog.kencogroup.com/why-an-internal-warehouse-quality-audit-is-critical-
to-your-warehouse-operations(myths; 21-02-18,23:54)
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•https://www.ava.gov.sg/docs/default-source/tools-and-resources/resources-for-
businesses/goodwarehousingpractices27sept11 (ideal points for audit, 14-03-2018)
•http://www.crs-csex.forces.gc.ca/reports-rapports/2014/208p0967-
eng.aspx(method; 21-02-18)
•https://distributiondesign.com/logistics-consultant-services/operational-audit-
operational-assessment/(operational audit areas, audit report)
•http://www4.ncsu.edu/~kay/Material_Handling_Equipment.pdf (material handling
in warehouse)
•https://www.pharmaguideline.com/2012/05/gmp-audit-check-list-weighing-
and.html(06-4-2018)

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