Standard Operating Procedure of Finished Product Samplings in Pharmaceuticals Plant SOP is describe in this post.
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1. Purpose:
1.1. To establish a procedure for sampling of finished goods.
2. Scope:
2.1. It is applicable to all finished products in all sections of Production Department.
3. Responsibilities:
3.1. Quality Assurance Manager
3.2. Quality Assurance Officer
3.3. Production Pharmacist
4. Procedure:
4.1. Q.A Officer after the final packaging of the product receives the request for analysis from Production Department.
4.2. Q.A officer collects the random sample from different shipper/cartons of Finished Product, number of total packs to be collected are specified in F-07-007, (Minimum Quantity of Finished packs for Retained Sample and Stability Studies),
4.3. Production Pharmacist enters the no. of packs taken by Q.A officer in log book of “Quantity of Retained Sample” (RSLB-05-005) and Q.A Officer will sign it after receiving the sample.
4.4. Q.A Officer then hand over the analysis request to Q.C Analyst for analysis of finished goods.
4.5. 1 finish pack (if required more than 1) is used for test/analysis at finished product stage, and the remaining packs are retained in Retained Sample Room in QC Lab.
4.6. Collected sample is recorded in QA register of Retained sample by QA Officer with:
4.6.1. Product Name
4.6.2. Mfg. Date
4.6.3. Exp. Date
4.6.4. No. of packs taken
4.6.5. Date of sampling
4.6.6. Signature
4.7. Q.C Manager will issue the finished product test report after the sample has been analyzed as per specifications.
4.8. Retain sample packs are stored in Retained Sample Room; maintained at temperature NMT 30oC ±2oC and NMT 60% ± 5% Relative Humidity.