ETHIOPIAN PHARMACEUTICAL MANUFACTURING SH. CO.
Page 1 of 3
EPHARM QUALITY ASSURANCE DEPARTMENT
“Quality is our most
important product”
SOP Number: WH-003
Title: Standard Operating Procedure for Material Receiving, Segregation, Storage and
Distribution
Revision Number 01 Supersedes 00
Prepared By : Samuel Mengistu Signature ________________Date_______________
Checked By : Mosis Adugna Signature_________________Date_______________
Authorized By : Shimelis Ayele Signature_________________Date_______________
Effective Date: Nov. 28, 2014 Revision Date: Nov. 28, 2016
1.Purpose
The purpose of this SOP is to ensure that goods are received, checked, stored, delivered and returned in a
consistent manner.
2.Scope
This procedure applies to all incoming materials that are stored in company’s ware house.
3.Validity
This SOP is valid up to the next revision date and only if it bears the control seal.
4.Responsibility
The store keeper and the head of property division are responsible for the implementation of this SOP
5.Materials and Equipment
None
6. Procedure
6.1 RECEIVING GOODS
6.1.1 Components (raw materials), drug product containers and closures, packaging and labeling
materials shall be physically inspected on receipt for correct labeling( batch no, name of the
material and exp. date), correctness of supplier( according to approved supplier’s list),
correctness of container/packaging material as stated in the material specification, integrity
(damage) of the container or closure system, physical contamination with dirt of the container
closure system and for agreement between quantity ordered and quantity supplied.
6.1.2 All components, drug product containers and closures, packaging and labeling materials that
has passed the inspection process shall be thoroughly cleaned from any dust that may present
on the container closure system before entry to ware house at the receiving bay.
6.1.3 All activities performed shall be filled on the check list for material receiving.
6.2 SEGREGATION:
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ETHIOPIAN PHARMACEUTICAL MANUFACTURING SH. CO. Page 2 of 3
EPHARM QUALITY ASSURANCE DEPARTMENT
“Quality is our most
important product”
SOP Number: WH-003
6.2.1. All components, drug product containers and closures, packaging and labeling materials
whose container closure systems are grossly damaged or contaminated with foreign
matter shall be segregated and separately quarantined pending decision on their future.
6.2.2. All components, drug product containers and closures, packaging and labeling materials
that have not been approved by the QC shall be quarantined and stored separately in a
quarantine area and withheld from use until such approval is secured from the QC.
6.2.3. All components, drug product containers and closures, packaging and labeling materials
that have been approved by the QC shall be labeled with proper QC approval label and
stored in a separate area designated for approved materials.
6.2.4. All components, drug product containers and closures, packaging and labeling materials
that have been rejected by the QC shall be labeled with proper QC rejection label and
shall be removed immediately and quarantined in a reject area designated for such
materials pending destruction.
6.3 STORAGE
6.3.1 All components, drug product containers and closures, packaging and labeling materials
shall be stored in a clean store, off the ground, in a manner that would permit easy
cleaning and identification.
6.3.2 The temperature and humidity of the storage facility shall be monitored and recorded on a
three times daily i.e. in the morning, mid day and before the end of work.
6.3.3 Labels and labeling materials for different products or different strengths of the same
product are to be kept separate – often by the use of drawers, cubicles or cupboards, so as
to minimize the potential for mix-ups, free from dirt and dust and at controlled humidity
condition.
6.4. DELIVERY OF GOODS
6.4.1. Issue and distribution of all components, drug product containers and closures, packaging
and labeling materials and drug products shall be only for those materials which have QC
approval slip and shall be in writing and the records are to be signed, approved and
maintained.
6.4.2. Appropriate stock rotation procedure shall be implemented to allow the use of first
approved material to be used first. This requirement may be modified if there is any
justification and shall be approved.
7. Reporting/Records
Checklist for the receipt and segregation of materials shall be correctly filled and recorded.
Confidential
ETHIOPIAN PHARMACEUTICAL MANUFACTURING SH. CO. Page 3 of 3
EPHARM QUALITY ASSURANCE DEPARTMENT
“Quality is our most
important product”
SOP Number: WH-003
Temperature and relative humidity follow-up record log book
Requisition form, Purchase Order form, Goods return form shall be filled
8. Reference Documents: Nil
Confidential
