Finished Product Release
- Preparation and approval of detailed instructions for carrying out tests, based
on the specifications laid down by Loan License parties and Pharmacopoeia. Instruction
include test methods for raw materials, chemicals intermediates, in-process materials,
packaging materials and finished goods. (Q.C)
- Sampling of Raw materials, Packaging materials in-process and Finished Products
as per the sampling plan. (Q.C)
- Testing of Raw materials, packaging materials, in process and finished goods.
- Releasing/rejecting raw materials and packaging materials. (Q.C)
- Establishing and revising control procedures and specifications. (Q.C)
- Evaluating the stability of finished goods. (Q.C)
- Ensuring that Good Manufacturing Practices are adhered to during all manufacturing
- Reviewing and approving batch manufacturing records prior to release. (Q.A)
- Releasing/Rejecting finished goods. (Q.A)
- Documentation, this include preparation of SOPs & maintenance of records.
- Investigation of market complaints, maintaining records and suggesting corrective
- Conducting Internal GMP Audits. (Q.A)
- Examination of goods returned from the market and suggest redressing/Destruction
of the same. (Q.A)
- Validation of process. (Q.A / Q.C / Prodn)
: Finished Products are released by Q.A.
after analysis of the batch, a certificate of analysis is generated for the batch
which is signed by the chemist and countersigned by Q.C. Incharge. The batch production
records and analytical records are reviewed by Q.A. Manager and Countersigned. Status
of the finished product is informed to the Technical Director with the Remark "Approved/Rejected"
as the case may be.