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SOP for Sampling of Packaging Materials

To lay down a procedure for the sampling of packaging materials (printed and unprinted) for Production.

This procedure applies to the Sampling of Packaging Materials at Pharmasky Limited.

The Chemist / Assistant - Quality Control Packaging shall be:
  • Responsible for receiving the GRN and entering the details in Packaging Material register.
  • Responsible for the ensuring appropriate cleanliness of sampling area and integrity of consignment.
  • Responsible for ensuring proper documentation for sampling and assembling of adequate number of samples for analysis purpose.
  • Responsible for proper sampling of PM as per Military Standard 105 D from the pack (s) and its appropriate identification on each sampled container (s).
  • Responsible for carrying out analysis of material (s) accurately & precisely.
  • Responsible for maintaining the Reserve Sample and it’s Record.
  • Responsible for ensuring proper labelling on packs.
  • Responsible for recording the data in the sampler’s remarks and test data sheet.
  • Responsible for intimating to Executive – QC, in case of any non-conformance.

The Executive - Quality Control shall be:
  • Responsible for verifying the recorded data of sampled consignment by Quality Control – Officers and review of the same.
  • Responsible for updating the document as per regulatory requirement
  • Responsible for imparting training to sub-ordinates.
  • Responsible for taking decisions on non-conformance in co-ordination with Head – Quality Assurance / Quality Control

Manager – Quality Control

  • Receive Goods Receipt Note (GRN) from Warehouse and record relevant information in packaging material register
  • Take out Photocopy of Sampler’s Check List - PM
  • The separate sampler’s remark shall be used for each lot of Batches.
  • Prepare the “UNDER TEST” label from the computer system to affix on the consignment.
  • Check the delivered items to ensure that the quantity received corresponds with the GRN Quantity
  • Fill the necessary details in Sampler’s Check List by taking the reference of Goods Receipt Note (GRN). If a discrepancy is found in GRN inform to the warehouse for corrective action.
  • Go to the Quarantine area and identify the material to be sampled from the Quarantined label which is affixed by Warehouse on the packs.
  • In the case of Aluminium and PVC foils carry out the sampling under Laminar Air Flow (LAF).
  • Cleaning of LAF shall be carried out on every alternate day or early if required. The LAF shall be cleaned with wet mop followed by dry mop.
  • The cleaning shall be recorded in the cleaning record for LAF
  • Ensure that the surrounding area is clean, if not get it clean, prior to start of the sampling.

  • Check the packing condition of the material and details mentioned on the Under Test labels.
  • Verify that the Quarantine Labels are affixed by Warehouse Personnel.
  • In case of any discrepancies intimate to Executive / Head - Quality Assurance or Head - Quality Control for necessary action.
  • Ensure that packs are cleaned externally and open the packages only after ensuring the proper cleaning. Observe the material for any abnormalities and record it on the Sampler’s Check List.
  • Check the following points during sampling of the material:

  • Mode of packing,
  1. Indication of packing,
  2. Details available on pack (Containers),
  3. No. of packs (containers) received,
  4. Total quantity received,
  5. No. of packs (containers) sampled,
  6. Quantity to be sampled.
  7. Name of the person who sampled along with date of sampling.

  • Withdraw the samples randomly by opening different containers / Boxes as per n+1 and take out sampling quantity for visual inspection as per sampling plan MIL – STD 105D Acceptable Quality Level (AQL).
  • Note down the sampled quantity in Sampler’s checklist based on the number of packages to be sampled.
  • Examine the sampled material as per AQL against the approved standard for general appearance, deviation from normal visual quality, colour, text etc. wherever applicable.
  • Record the results in the approved Visual Inspection Report for Aluminium foil and PVC Foil.
  • After completion of sampling the material pack shall be resealed with BOPP Tape or tied with the help of a cable – tie.
  • Affix the “UNDER TEST” to all the rolls of sticker labels, foils and every container of rubber plugs. For all other packaging materials at least one “UNDER TEST,” Label shall be affixed on the bottom container/ pack of each pallet.
  • Affix the SAMPLED BY QC sticker label duly signed and mentioning the container number according to the sampling plan, on an outer container of the material from which the sample is taken.
  • Check that the number of packs is correct as mentioned in under the test label.
  • Take out composite sample for analysis as per respective Packing Material Specifications. Put the sampled quantity in a self-sealing polybag bearing the label of “SAMPLE FOR ANALYSIS”
  • Carry out testing of the packaging material as per the laid down specifications of the respective material.
  • The sampling procedure described above will not be applicable to Tertiary Packaging materials like shippers, pads, partitions,s and corrugated trays. For these materials, only one unit shall be collected, and carry out the analysis as per laid down specifications.


Q.A : Quality Assurance
Q.C : Quality Control
SOP : Standard Operating Procedure
No. : Number



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