Standard Operating Procedure for Annual Product Quality Review (APQR)

1) Purpose

This SOP outlines the procedures for conducting annual product quality reviews (APQRs) to evaluate the quality and performance of 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 the APQR process. Production, quality control, regulatory affairs, and other relevant departments are responsible for providing necessary data and information for the review.

4) Procedure

4.1 APQR Initiation

1. Initiate the APQR process for each marketed pharmaceutical product on an annual basis.
2. Identify the reporting period and products to be included in the review.

4.2 Data Collection

1. Collect relevant data and information from various sources, including batch records, analytical data, stability studies, complaints, deviations, and any changes made during the reporting period.
2. Ensure data completeness and accuracy for reliable review and assessment.

4.3 Review and Evaluation

1. Review the collected data to assess product quality attributes, process performance, and compliance with approved specifications and regulatory requirements.
2. Evaluate trends, deviations, and any out-of-specification results identified during the reporting period.

4.4 Trend Analysis

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

4.5 Product Performance

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

4.6 Documentation and Reporting

1. Document the findings and conclusions of the APQR in a comprehensive report.
2. Include recommendations for improvements or changes to maintain or enhance product quality and compliance.

4.7 Management Review

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

5) Abbreviations, if any

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

6) Documents, if any

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

7) Reference, if any

Regulatory requirements and guidelines for APQR, such as ICH Q7, ICH Q9, ICH Q10, and FDA Guidance for Industry: Annual Product Review.

8) SOP Version

Version 1.0