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Sampling of In-process blends, uncoated tablets, coated tablets and filled capsules

  • OBJECTIVE :
  • To provide procedure for representative sampling of  In-process blends,
  • uncoated tablets, coated tablets and filled capsules.
  • RESPONSIBILITY :
  • Officer – Quality Assurance.
  • Head – Quality Assurance to ensure compliance.
  • PROCEDURE :
  • After receiving the “Inprocess Analysis Request and report / Inprocess analysis
  • request for commercial batches/Analysis Request “(Annexure -1a,1b,1c respectively)
  • from Production department, the  concerned QA Officer shall fill the “Sample for
  • testing ” labels (Annexure -2)
  • Before collecting the samples check that all the containers are labeled with
  • “Product label” (Annexure -2).
  • During sampling, the  concerned person shall put on Hand gloves and wear mouth
  • mask. Sample shall be collected with clean and  dry  stainless  steel  spoons/thieves
  • in  clean and dry suitable size HDPE/Glass containers with proper closures.
  • Inprocess blend samples of about 25 gms as pooled sample shall be collected from
  • upper, middle and bottom layers from containers / bins using sampling thieves.
Total No. of

containers/bins

Sample quantity of blend
1 about 25 g
2 Collect about 12.5g from each container/bin and mix
3 or more Collect about 10 g from each container / bin and pooled
the sample from that 25 g collect.
  • Officer – QA shall follow the collection of the unit dose sampling for blend uniformity
  • as per SOP “Unit Dose sampling procedure for blend uniformity”.
  • For uncoated tablets, coated tablets and filled capsules, samples shall be collected from all the containers in the following manner.
Total No. of

containers

Sample quantity of

tablets/capsules

1 about 250
2 Collect about 125 from each container and mix
3 Collect about 80 from each container and mix
4 Collect about 60 from each container and mix
5 Collect about 50 from each container and mix
6 Collect about 40 from each container and mix
7 Collect about 35 from each container and mix
8 or more Collect about 30 from each container and mix, from there take 250.
  • Label the sample HDPE/Glass container with ‘Sample for testing’ (Annexure -2).
  • Affix “Under Test” label on the product label.
  • After completion of sampling, the concerned QA Officer shall fill the “Inprocess Analysis Request and Report/Analysis Request” with all data and sign with date.
  • QA Officer shall send the samples alongwith the “Inprocess Analysis Request and Report/Inprocess analysis request for commercial batches/Analysis Request” to QC department.
  • The concerned QC Officer shall enter the details of the sample in the AR Register – Formulations (Annexure-3) and allot A.R No.
  • The concerned QC Officer shall enter the A.R. No. on the “Inprocess Analysis Request and Report/Inprocess analysis request for commercial batches/Analysis Request” and “Sample for Testing” label.
  • Forms and Records (Annexures)
  • Specimen format of “Inprocess Analysis Request and report / Inprocess analysis request for commercial batches/Analysis Request “- Annexure -1.
  • Specimen of labels ” Product Label”, “Sample for testing” and “Under test ” Annexure-2.
  • Specimen format of “AR Register – Formulations” – Annexure 3.
  • Distribution
  • Master copy –  Quality Assurance
  • Controlled copies- Quality Assurance, Production, Quality Control.engineering

Annexure -1

Specimen format of “Inprocess Analysis Request and report / Inprocess analysis request for commercial batches/Analysis Request “

  • PILOT  PRODUCTION/PRODUCTION
  • Request No.:
  • Date:
  • Product :
  •  Batch Number :
  •  Batch Size :
  •  Mfg. Date :
  •  Stage :
  •  Average weight :
  • Analysis Required :
  •  Sample Quantity
  •  PO(Sign./Date)
  •  QAO (Sign./Date)
  • AR No. :

Annexure-2.

Specimen of labels ” Product Label”, “Sample for testing” and “Under test ” 

  • PRODUCT LABEL
  • Product  :
  • Batch No. :
  • Batch size. :
  • Stage :
  • Container No. :
  • Gross weight :
  • Tare weight :
  • Signature :
  • Net weight :
  • Date :
  • CHEMINOR
  • SAMPLE FOR TESTING
  • Product :
  • Batch No.:
  • ARNo. :
  •  Stage :
  •  Mfd. :
  • Sampled by :
  • Sampled on :
  • CHEMINOR
  • UNDER TEST
  • Product :
  • Batch No. :
  • Stage :
  • Batch Size :
  • Mfd.:
  • Exp. :
  • Sampled on :
  • Container No.:
  • Signature :
  •  CHEMINOR

 Annexure-3

Specimen format of “AR Register – Formulations”

Name Stage Batch/Lot No. Date of Mfg. Date of expiry Batch size AR. No Sampled on Sample received on Approved/Rejected

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