STANDARD OPERATING PROCEDURE FOR ANNUAL PRODUCT REVIEW

1.       Purpose

1.1. The purpose of this document is to describe the procedure for annual review of products manufactured during a year.

2.       Scope:

2.1. It is applicable to Quality Assurance Department.

3.       Responsibility:

3.1. Quality Assurance Manager

4.       Procedure:

4.1. Annual product review shall be conducted each year in the month of January.

4.2. Product review shall be based on following critical parameters of product batches:

§  Assay

§  PH

4.3.  Review shall be done for all batches of each product manufactured during a year.

4.4. Annual Product Review (APR) report shall be generated after completion of product batch data and signed by concerned authorized personnel.

4.5. Recommendations on deviations shall be forwarded to production department for necessary action.

5.       List of Recipients:

5.1. Quality Assurance Manager

6.       Attached Forms/ Annexures:

6.1. Annual Product Review (APR) format