Standard Operating Procedure of Finished Good Review in Pharmaceuticals is describe in this post.
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1. Purpose:
1.1. To provide the guidelines for the final inspection and review of all necessary documentation that has been generated during Production and Quality Control of the finished product.
2. Scope:
2.1. It is applicable to all finished product ready for shipment at Pharmaceuticals.
3. Responsibilities:
3.1. Quality Control Manager.
3.2. Quality Assurance Manager.
3.3. Quality Assurance Officer.
4. Procedure:
4.1. Production Manager and Quality Assurance Manager / Incharge are responsible for ensuring that the batch records meet these criteria.
4.2. Production Manager and Quality Assurance Manager complete an individual review of the documents, and sign and date the review section indicating that they are satisfied with all the information included.
4.3. Quality Control Manager is responsible for the completion and documentation of all the testing performed in the Quality Control Laboratory, sign the documents and date the review section of all the Batch Analysis Sheet.
4.4. Quality Assurance Manager after a careful & complete review of all the documents designates Quality Officer to enter information regarding the finished product in the Finished Product Review Log Book. Then Quality Assurance Manager issues a certificate of review to the Production Officer (Packaging).
4.5. The Quality Control Officer issues Released card to the concerned Production Officer (Packaging) against the batch.
4.6. The concerned Production Officer (Packaging) transfers all the finished products to the Finished Goods Store .
4.7. Quality Assurance Manager also has the authority and responsibility to inspect at random any In process Operation for compliance, uniformity of material and any other aspect of the production to test operations that may affect the identity, strength, purity or quality of the finished product
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