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Finished pdt. release 112070804015

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  • 1. FINISHED PRODUCT RELEASE, QUALITY REVIEW AND BATCH RELEASE DOCUMENT GUIDED BY: MR PRATIK NAYAK PREPARED BY: JINAL PATEL M.Pharm (Q.A) Sem-1
  • 2. DEFINITION  These are the products that has been undergone all stages of production, including packaging in its final container & labeling.  SPECIFICATIONS
  • 3. FINISHED PRODUCT RELEASE  FINISHED PRODUCT RELEASE A Product in the marketable pack is classified as finished product. Practically a transportable pack, i.e. a shipper containing the salable pack (in retail) is considered the finished product.
  • 4. SOP ON RELEASE  Who is the authority to release a batch?  “Authorized person”  Quality assurance head  Any other person suitably authorized  Completed batch production & control record.  Test reports of In Process Quality control.  Test reports of finished product analysis.
  • 5. WHO Guidelines :  WHO Guidelines Finished product should be held in quarantine until their final release, after which they should be stored as usable stock under conditions established by the manufacturer.
  • 6. Sampling SAMPLING PLANS  Attributer Plans  Variable plans
  • 7. Sampling lables Material code Material description Lab. Batch number Manufacturing batch no. Sample Qty. Date Containor no.
  • 8. Sampling techniques:  No Inspection  . Small Samples.  Large Samples.  100% Inspections.
  • 9. TESTING  Pre Testing Part  Testing Part  Post Testing Part
  • 10. QUALITY REVIEW  Quality reviews are planned and documented inspections of a review item. The review item may be a product, a group of related products or part of a product.
  • 11. THREE PHASES Phase 1 – preparation Phase 2- The review meeting Phase 3 – the follow up action
  • 12. BATCH RELEASE DOCUMENTS 1. BATCH RELEASE This department, which is part of the "quality control unit," gives the final approval in order to release a product to the market.  2.QUALITY ASSURANCE  QA functions as the company's internal quality auditing and compliance group.  3.RECEIVING AND SHIPPING  4.REGULATORY AFFAIRS
  • 13. • 5.TRAINING DEPARTMENT  6.VALIDATION DEPARTMENT Validation protocoal
  • 14. REFERENCE  Willing.H.S,Good Manufacturing practices for Pharmaceuticals, Fourth Edition, Marcel Dekker,Vol-78,Pg no.-13-21.  Potdar.A.M,Current GMP For Pharmaceuticals,Pharma Med Press,Pg.no.-127.  Sharma.P.P,How to practice GMP,Third Edition,Vandana Publications,Pg no.-68,287.  Nally.D.J,GMP Practices for pharmaceuticals, Marcel Dekker,Vol-169,Pg.no.13.  Shah.H.D,Q.A Manual, First Edition, Business Horizons,Pg.no.-142-151.  www.cgmp.com/qcRelease.htm  www.authorstream.com/.../arparmar88-1201126- finished-product-rel..