SOP Number: QA-014

SOP Number:QA-014
Title: Standard Operating Procedure for Damaged and Expired Materials Handling
Revision Number 01 Supersedes 00
Prepared By :

1.Purpose
To handle damaged and expired raw and packing materials and provide a means to control the
contamination impact through careful handling at receiving, storage and shipping.
2.Scope
This procedure applies to both newly coming and stored damaged and expired materials that directly affect the
quality of the company’s products.

3.Validity
This SOP is valid up to the next revision date and only if it bears the control seal.

4.Responsibility
Property Administration division head, Store heads, QA/QC
5.Materials and Equipment
Camera
6. Procedure
6.1 On receipt of a damaged/ Expired shipment the receiver will:

6.1.1. Take a photo of the damaged/expired material and ensure the truck driver signs on the receiving
document as evidence.
6.1.2. Notify QA
6.1.3. On being notified of a damaged/expired material QA will inspect the damaged/expired material
and note the damage on the PO (purchase order) and receiving documents.
6.1.4. Place the damaged/expired product in separate area dedicated for storing damaged/ expired
materials, until notification is received from the Procurement and Supply Manager to return or
destroy.
6.1.5. Label damaged product with all information: name, lot number, quantity, purchase order number,
date and reason for rejection using rejection tag.
6.1.6. Attach the picture to the signed Purchase Order and pass to the Procurement and Supply
Manager.
6.1.7. Contact the supplier/insurance for a claim.
6.1.8. If product is to be disposed, follow SOP for Product Disposal(WI/ EPHARM /10/002)

6.2 For materials that have been stocked in ware house

6.2.1 For materials that are expired and/ or their retest period has reached follow SOP number PCQC-
168.
6.2.2 If the result for the retest fails to meet the acceptance criteria, place the expired material separate
area dedicated for storing damaged/ expired materials.
6.2.3 For damaged materials during storage process, notify QA for further inspection if the material
can have a deteriorating impact on the final products.
6.2.4 If the inspection result shows insufficiency in meeting the requirement, keep again these
 SOP Number: QA-014

materials in separate area dedicated for storing damaged/ expired materials.

6.2.5 Notify the QA in periodic basis of three months the status of the damaged/ expired materials
using OF/EPHARM/10/101.
6.2.6 If product is to be disposed, follow SOP for Product Disposal(WI/ EPHARM /10/002)
7. Reporting
Receiving Log., QC Rejected tags, QC On Hold tags.
Damaged or Expired Materials Notification Form( OF/EPHARM/10/101)
8. Reference Documents: Nil

Company Name:

የኢትዮጵያ መድኃኒት ፋብሪካ አ·ማ·

Ethiopian Pharmaceuticals Manufacturing Sh. Co.
Document No: Title: Issue No. Page No.
:
OF/EPHARM/10/101 1 Page 1 of 1
Damaged or Expired Materials Notification
Form

S/N Name of Material Batch No. Origin Company Remark

SOP Number: QA-014