1.0 OBJECTIVE:To lay down the procedure for sampling of Packing material.
2.0 SCOPE:This SOP shall be applicable to Quality Control Dept.
3.0 RESPONSIBILITY:Quality Control Supervisor
4.0 ACCOUNTABILITY:Sr. Manager Quality Assurance
5.0 PROCEDURE:5.1 The intimation of receipt of material shall be received through G.R.N which shall be sent by the store personnel.
5.2 Entry of the material received shall be made in the packing material entry register.
5.3 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.
5.4 Ensure that the Q.C person goes for sampling with scissor, labels and requisition book.
5.5 Check the labels on the containers and compare with G.R.N details for which sampling should be done. Send the sampling report to Sr.Manager Quality Assurance on noticing any discrepancy.
5.6 Sampling shall be done from each and every pack for printed packaging material (labels, cartons etc.)
5.7 Carry out sampling as per following plan.
5.7.1 Open the containers of one consignment.
5.7.2 Sample the material from each container for printed packaging material (labels & cartons).
5.8 Sample collected shall be sufficient for carrying out the analysis as per testing specifications, twice.
5.9 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.
5.10 Ensure proper closure of the sampled containers and affix “ Q.C SAMPLED” & “UNDER TEST” label on the containers duly signed by the Supervisor.
5.11 “Released” / “Rejected” slips should be pasted after complete analysis, duly signed by the Supervisor.
Related: SOP for Testing and Release/Rejection of Packing Materials
6.0 ABBREVIATIONS:6.1 SOP : Standard Operating Procedure
6.2 QA : Quality Assurance
6.3 QC : Quality Control
6.4 Dept. : Department
6.5 G.R.N : Goods Receipt Note
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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