Finished Good Review SOP

Finished Good Review SOP

1.0   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.

2.0    SCOPE:

2.1.         It is applicable to all finished product ready for shipment at ________Pharmaceuticals.

3.0   RESPONSIBILITY:

3.1.      Quality Control Manager.

3.2.      Quality Assurance Manager.

3.3.      Quality Assurance Officer.

4.0    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 through Product Transfer Ticket.

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

5.0    QUALITY FORMS AND RECORD:

N/A

6.0      RISK ANALYSIS

EVIDENCES OF RECORDS & REFERENCES		Log Book of Finished Goods. BMRs
FORMAL KPIs (Key Performance Indicators)		Retrieval and access is easy and possible as and when required.
GENERAL RISKS		CONTROL   MEASURES	CUSTODIAN
Risks	Impact
Finished Goods review not occurs properly and on time and by authenticated person.	Batch documents mix up may occurs.	Maintain log Book and BMRS by authenticated person and reviewed on time.	QA Officer QA Manager Store Incharge