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..