SOP for Sampling of Packaging Materials

OBJECTIVE

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

SCOPE

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

RESPONSIBILITY

The Chemist / Assistant - Quality Control Packaging shall be:

• Responsible for receiving the GRN and entering the details in the Packaging Material register.
• Responsible for the ensuring appropriate cleanliness of the sampling area and integrity of consignment.
• Responsible for ensuring proper documentation for sampling and assembling of an adequate number of samples for analysis purposes.
• 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 the material (s) accurately & precisely.
• Responsible for maintaining the Reserve Sample and its Record.
• Responsible for ensuring proper labeling 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

ACCOUNTABILITY

Manager – Quality Control

PROCEDURE

• Receive Goods Receipt Note (GRN) from the Warehouse and record relevant information in the packaging material register
• Take out Photocopy of Sampler’s Check List - PM
• The different sampler’s remark shall be used for each lot of Batches.
• Prepare the “UNDER TEST” label from the computer system to affix to the consignment.
• Check the delivered items to ensure that the quantity received corresponds with the GRN Quantity
• Fill in the necessary details in Sampler’s Checklist by taking the reference of Goods Receipt Note (GRN). If a discrepancy is found in GRN inform 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 the 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 a wet mop followed by a 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 the start of the sampling.

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• 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 the Executive / Head of quality Assurance or Head of 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 the 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 the 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, color, 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 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 “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, and corrugated trays. Only one unit shall be collected for these materials, and carry out the analysis as per the specifications.

REFERENCE

Nil

ABBREVIATION

Q.A: Quality Assurance

Q.C: Quality Control

SOP: Standard Operating Procedure

No. : Number

ANNEXURE

Nil

REVISION HISTORY

Nil

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