Standard Operating Procedure for Product Quality Review

1) Purpose

This SOP outlines the procedures for conducting and documenting product quality reviews to evaluate the quality and compliance of marketed pharmaceutical products.

2) Scope

This SOP applies to all pharmaceutical products marketed by the organization, including finished dosage forms, active pharmaceutical ingredients (APIs), and intermediates.

3) Responsibilities

The Quality Assurance Manager or designated personnel are responsible for overseeing product quality reviews. Production, quality control, regulatory affairs, and other relevant departments are responsible for providing necessary data and information for the review.

4) Procedure

4.1 Annual Product Review (APR)

1. Initiate the annual product review process for each marketed pharmaceutical product.
2. Collect and compile relevant data and information, including batch records, stability data, complaints, deviations, and any changes made during the reporting period.

4.2 Review and Evaluation

1. Review the collected data and information to evaluate the quality and consistency of the product.
2. Assess compliance with approved specifications, regulatory requirements, and internal quality standards.

4.3 Trend Analysis

1. Perform trend analysis on critical quality attributes, process parameters, and any other relevant data to identify trends or potential issues.
2. Compare current data with historical data and identify any significant changes or deviations.

4.4 Product Performance

1. Evaluate product performance based on stability studies, customer complaints, returns, and adverse events.
2. Assess the need for any corrective or preventive actions (CAPA) based on the review findings.

4.5 Documentation and Reporting

1. Document the findings of the product quality review in a comprehensive report.
2. Include recommendations for improvements or changes, if necessary, to maintain or enhance product quality.

4.6 Management Review

1. Present the product quality review report to senior management or the quality review board for review and approval.
2. Discuss any significant findings, trends, or recommendations for further actions.

5) Abbreviations, if any

SOP: Standard Operating Procedure
APR: Annual Product Review
CAPA: Corrective and Preventive Actions

6) Documents, if any

Annual Product Review Reports, Batch Records, Stability Data, Complaints and Returns Records, Deviation Reports

7) Reference, if any

Regulatory requirements and guidelines for product quality reviews, such as ICH Q7, ICH Q9, ICH Q10, and FDA Guidance for Industry: Product Quality Reviews.

8) SOP Version

Version 1.0