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

PURPOSE
To lay down a procedure for the sampling & handling of Semi finished & finished product.

SCOPE
This procedure is applicable to the sampling & handling of Semi finished & finished product.

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 the sampling of bulk.
  • 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 sample is to be collected. The label shall bear 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 number of 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 pool them as Semi finish 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 Sample of 40 tablets shall be sent to QC for analysis with requisition slip.

The finished products shall be sampled as per the following procedure:
  • For Finished product sampling Production department shall send 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 finish good sample at the beginning, middle and the end of the packaging operation.
  • The quantity of Finish samples for products shall be collected as follows:
Tablet - 40 tablets
Liquid Oral - 10 Bottle
Lotion & cream -10 Nos
Soap - 10 Nos
  • Affix stickers on control samples on each sample collected during packing operation at different interval of packing operation and submit to concern person deputed by Head Quality Assurance Department.
  • Pooled Sample shall be sent to QC for analysis with requisition slip.
ANNEXURES
Nil

ABBREVIATIONS
SOP  :  Standard Operating Procedure
QA  :  Quality Assurance
IPQA  :  In Process Quality Assurance

REVISION HISTORY
Nil

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