Standard Operating Procedure for Sampling of Packing Materials

  1. OBJECTIVE:

To lay down a procedure for sampling of packing materials.

  • SCOPE:

This procedure is applicable for procedure for sampling of packing materials.

  • RESPONSIBILITY:

QC Officer/ QC Executive

  • ACCOUNTABILITY:

QC Manager.

  •  PROCEDURE:
    • Requirements:
      • Seizer, Inches tape, Poly bag.
    • Procedure:
      • The intimation of receipt of material shall be received through G.R.N which shall be sent by the store personnel.
      • Entry of the material received shall be made in the Packing material inward register.
      • 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.
      • Ensure that the Q.C person goes for sampling with scissor, labels and requisition book.
      • 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.
      • Sampling shall be done from each and every pack for printed packaging material (labels, cartons etc.)
  • Carry out sampling by √n+1.Open the containers of one consignment.
  • Sample the material from each container for printed packaging material (labels & cartons).
  • Sample collected shall be sufficient for carrying out the analysis as per testing specifications.
  • If received less than or equal to 5 containers; should be open 100% containers for sampling. Check all the containers physically.Each sample container should bear a label indicating:Name of the sampled material.
  • Signature of the person who has taken the sample.
  • Date of sampling.Ensure proper closure of the sampled containers and stamped mark on sample bag & “UNDER TEST” label on the containers duly signed by the Supervisor.“Approved” / “Rejected” slips should be pasted after complete analysis, duly signed by the Supervisor.
  • Details of products including product name, batch no., batch size, mfg. date, exp. Date, no. of containers manufactured by & supplier by are checks and fill in packing materials checklist.
  • Analysis the packing materials with specific protocol for packing materials.
  • TRAINING:

Trainer   : Manager – Quality Control

Trainees : Staff of the QC departments

  • DISTRIBUTION:

Master Copy                  :           QA Department

Controlled Copy            :           QC Department

Display Copy                 :           QC Department

  • REFERENCES:

In-House

Bhanu Pratap Singh

BHANU PRATAP SINGH IS EXPERIENCED IN PHARMACEUTICAL, AUTHOR AND FOUNDER OF PHARMACEUTICAL GUIDESLINE (WWW.PHARMAGUIDESLINE.COM), A WIDELY READ PHARMACEUTICAL BLOG SINCE 2019. EMAIL:- INFO@PHARMAGUIDESLINE.COM

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