Finished pdt. release 112070804015

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Finished pdt. release 112070804015

  1. 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. 2. DEFINITION  These are the products that has been undergone all stages of production, including packaging in its final container & labeling.  SPECIFICATIONS
  3. 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. 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. 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. 6. Sampling SAMPLING PLANS  Attributer Plans  Variable plans
  7. 7. Sampling lables Material code Material description Lab. Batch number Manufacturing batch no. Sample Qty. Date Containor no.
  8. 8. Sampling techniques:  No Inspection  . Small Samples.  Large Samples.  100% Inspections.
  9. 9. TESTING  Pre Testing Part  Testing Part  Post Testing Part
  10. 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. 11. THREE PHASES Phase 1 – preparation Phase 2- The review meeting Phase 3 – the follow up action
  12. 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. 13. • 5.TRAINING DEPARTMENT  6.VALIDATION DEPARTMENT Validation protocoal
  14. 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..

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