1. Objective:

To lay down a procedure for finished product inspection and release.

  1. Scope:

This procedure is applicable for all type of finished pharmaceutical product.

  1. Responsibility:

Quality assurance, Warehouse and Production.

  1. Procedure:

4.1 Physical inspection of finished goods:

4.1.1  Check the quarantine label has been attached on each pallet/shipper.

4.1.2  Check that the information on the quarantine label is correct.

4.1.3  Select the shipper randomly as per below sampling plan:

Shipper checking policy
Sr. No. Total No. of shipper in the batch Number of shippers to be checked Sr. No. Total No. of shipper in the batch Number of shippers to be checked
1 1-2 1 11 401-450 26
2 3-10 2 12 451-500 29
3 11-50 3 13 501-550 32
4 51-100 5 14 551-600 35
5 101-150 8 15 601-650 38
6 151-200 11 16 651-700 41
7 201-250 14 17 701-750 44
8 251-300 17 18 751-800 47
9 301-350 20 19 801-1000 50
10 351-400 23 20 >1000 55

 

Inner carton checking policy
Sr. No. Total number of inner cartons per shipper Number of inner cartons to be checked
1 1-2 1
2 3-50 3
3 51-100 4
4 101-150 5
5 151-200 6
6 201-250 7
7 >250 8

4.1.4  Check the below parameters and record in inspection report.

Shippers: Correctness of seal, number of inner cartons, correctness of quarantine tag.

Inner carton: Legibility of batch details, appearance of inner carton

Leaflet: Availability of leaflet in inner carton, legibility of leaflet

Blister/strip/other: Quantity of blister/strip, Embossing/printing details

Label/Sticker: Adherence, correctness of batch details

Cap sealing: Intactness of sealing, correctness of batch details if any

Dispensing device: Availability of dropper, applicator etc if any

4.1.5 Reseal the shipper after inspection and sign on it.

4.1.6 Keep the inspection report with the batch document.

4.1.7 Sign in the quarantine label.

4.1.8 Ensure that the retention samples have been collected.

4.1.9 Send the batch documents to QA batch release team.

4.2 Batch document review and finished product release:

4.2.1 Review the batch document and ensure that the required informations are available.

4.2.2 Review that all the required information filled and meets acceptance criteria.

4.2.3 Review that calculations are done correctly.

4.2.4 Ensure signatures are present of concern personnel/operator wherever applicable.

4.2.5 Review all steps are followed as per recommended procedure.

4.2.6 Ensure all necessary samples are collected and mentioned properly.

4.2.7 Review the correctness of reconciliation at each step.

4.2.8 Put the signature of “released by QA” on batch document.

4.2.9 Issue batch release certificate and attach with batch document.

4.2.10 Issue a copy of batch release certificate to warehouse and affix the release label on shippers/pellets.

4.2.11 Release the stock either in electronic system or intimate the warehouse by release note.

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