SOP for Sampling & Handling of Semi-Finished & Finished Product

PURPOSE

To lay down a procedure for the sampling & handling of Semi-finished & finished products.

SCOPE

This procedure applies to the sampling & handling of Semi-finished & finished products.

RESPONSIBILITY

IPQA chemist

ACCOUNTABILITY

Head QA

PROCEDURE

Semi-finish samples for all the drug products shall be collected as follows:

• The production personnel shall submit a requisition slip ‘Requisition For Sampling And Testing’ to the In process.
• Quality Assurance personnel deputed at the production floor for bulk sampling.

• The sample shall be collected directly by the IPQA personnel.
• IPQA personnel shall affix a status label on the container (double polythene bag for solid samples and glass bottle / plastic bottles for liquid samples) in which the sample is to be collected. The label shall bear the sample name, batch no. / Lot no. (if any), Batch size, date of sampling, container number, and signature.
• For uncoated tablets, In-process sampling shall be done during compression. In these cases, 20-30 tablets shall be collected during in-process checks (as per predefined time-frequency; two hours in most of the cases) 10 to 20 tablets from these samples shall be collected in separately labeled containers and pooled as semi-finished samples.
• For coated tablets, sampling shall be done, lot-wise after completion of coating. Then lot-wise samples shall be mixed together to prepare a pool sample tablet for testing as a semi-finish.
• Pooled Samples of 40 tablets shall be sent to QC for analysis with a requisition slip.

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The finished products shall be sampled as per the following procedure:

• For Finished product sampling, the Production department shall send a Request slip to QA for sampling.

• Request slip shall be generated by Production through ERP.
• During the packaging operation, In process Quality Assurance personnel deputed at the production floor for the sampling of finished product shall withdraw the samples of finished drug product from the packaging line for testing and control samples.
• The IPQA personnel shall check and verify the packaging operation from the BPR and withdraw the finished good sample at the beginning, middle, and end of the packaging operation.
• The number of Finish samples for products shall be collected as follows:

1. Tablet - 40 tablets
2. Liquid Oral - 10 Bottle
3. Lotion & cream -10 Nos
4. Soap - 10 Nos

• Affix stickers on control samples on each sample collected during packing operation at different intervals of packing operation and submit to the concerned person deputed by the Head Quality Assurance Department.
• Pooled Samples shall be sent to QC for analysis with a requisition slip.

ANNEXURES

Nil

ABBREVIATIONS

SOP:  Standard Operating Procedure

QA:  Quality Assurance

IPQA:  In Process Quality Assurance

REVISION HISTORY

Nil

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