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Sop For Annual Product Review

The SOP describes the annual review procedure for products manufactured each year in January. The Quality Assurance Manager is responsible for reviewing critical batch parameters like assay and pH for each product. An Annual Product Review report is generated and recommendations for any deviations are provided to production.

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100% found this document useful (3 votes)
2K views1 page

Sop For Annual Product Review

The SOP describes the annual review procedure for products manufactured each year in January. The Quality Assurance Manager is responsible for reviewing critical batch parameters like assay and pH for each product. An Annual Product Review report is generated and recommendations for any deviations are provided to production.

Uploaded by

Prince Moni
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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SOP 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

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