Company Name:: Version No.
Humanwell Pharmaceutical Ethiopia PLC 1
Document No: Title: Page No.
SOP/QC/035 SOP for Sampling of Packing Material Page 1 of 3
Effective Date Revision Date
SOP for Sampling of Packing Material
Prepared by： X X
Department Name Date
Approved by： Y Y
Department Name Date
Authorized by： Z Z
Department Name Date
1. Purpose
Company Name:: Version No.
Humanwell Pharmaceutical Ethiopia PLC 1
Document No: Title: Page No.
SOP/QC/035 SOP for Sampling of Packing Material Page 2 of 3
Effective Date Revision Date
This procedure defines the procedure for sampling of Packing material.
2. Scope
This procedure is applicable for Quality Control Dept in Humanwell Pharmaceutical Ethiopia
PLC .
3. Validity
This SOP is valid only until next revision date and if it bears control seal.
4. Responsibility
It will be the responsibility of the Quality Control supervisor to follow the procedure.
Quality assurance manager is responsible for SOP compliance.
5. Material and Equipment
Scissor, labels and requisition book.
6. Procedure:
6.1. The intimation of receipt of material shall be received through G.R.N which shall be sent
by the store personnel.
6.2. Entry of the material received shall be made in the packing material entry register.
6.3. The QC Supervisor shall ensure that complete details of the material received are
available from the GRN. Any information not available from the GRN shall be obtained
from the stores section or the materials section at Head Office.
6.4. Ensure that the Q.C person goes for sampling with scissor, labels and requisition book.
6.5. Check the labels on the containers and compare with G.R.N details for which sampling
should be done. Send the sampling report to Quality Assurance on noticing any discrepancy.
6.6. Sampling shall be done from each and every pack for printed packaging material (labels,
cartons etc.)
6.7. Carry out sampling as per following plan.
Company Name:: Version No.
Humanwell Pharmaceutical Ethiopia PLC 1
Document No: Title: Page No.
SOP/QC/035 SOP for Sampling of Packing Material Page 3 of 3
Effective Date Revision Date
6.7.1. Open the containers of one consignment.
6.7.2. Sample the material from each container for printed packaging material (labels &
cartons).
6.8. Sample collected shall be sufficient for carrying out the analysis as per testing
specifications, twice.
6.9. Each sample container should bear a label indicating:
a. The name of the sampled material.
b. The signature of the person who has taken the sample.
c. The date of sampling
6.10. Ensure proper closure of the sampled containers and affix “ Q.C SAMPLED” &
“UNDER TEST” label on the containers duly signed by the Supervisor.
6.11. Released” / “Rejected” slips should be pasted after complete analysis, duly signed by the
Supervisor.
7. Abbreviations
SOP: Standard Operating Procedure
8. Related Documents /Applicable document/
None
9. Revision History
Version
Revision Description
No.
1 New
