1) SOP for Annual Product Review (APR)

2) Purpose

The purpose of this Standard Operating Procedure (SOP) is to define the procedures for conducting an Annual Product Review (APR) to assess product quality, consistency, and compliance with regulatory requirements. APR is essential for evaluating the overall performance of pharmaceutical products and identifying opportunities for improvement.

3) Scope

This SOP applies to all pharmaceutical products manufactured and distributed by the company, including finished dosage forms and active pharmaceutical ingredients (APIs).

4) Responsibilities

• Quality Assurance (QA) Department: Responsible for coordinating and overseeing the APR process.
• Production and Quality Control (QC) Departments: Responsible for providing relevant data and reports for APR.
• Regulatory Affairs: Responsible for ensuring APR compliance with regulatory requirements.
• Management: Responsible for reviewing and approving APR reports.

5) Procedure

1. Selection of Products for APR
   1. Identify pharmaceutical products eligible for APR based on predetermined criteria, such as sales volume, criticality, and regulatory requirements.
   2. Compile a list of selected products for APR review.
2. Data Collection and Review
   1. Gather relevant data and information from production records, QC testing results, stability studies, complaints, and regulatory submissions.
   2. Review manufacturing deviations, change controls, and any other relevant documents impacting product quality.
3. Analysis and Trending
   1. Analyze collected data to evaluate product quality attributes, including critical quality attributes (CQAs) and performance indicators.
   2. Identify trends and deviations from previous APRs, including any recurring issues or improvements.
4. Assessment of Compliance
   1. Evaluate product compliance with established specifications, regulatory requirements, and internal standards.
   2. Assess the effectiveness of corrective and preventive actions (CAPA) implemented since the last APR.
5. Reporting
   1. Prepare a comprehensive APR report summarizing the findings of the review.
   2. Include data analysis, trending charts, conclusions, and recommendations for continuous improvement.
6. Review and Approval
   1. Review the APR report with relevant departments and stakeholders.
   2. Obtain management approval of the APR report before finalization.
7. Archival and Documentation
   1. Archive the APR report and supporting documents in accordance with company document retention policies.
   2. Ensure that APR reports are accessible for regulatory inspections and audits.

6) Abbreviations, if any

• APR: Annual Product Review
• QA: Quality Assurance
• QC: Quality Control
• CQA: Critical Quality Attribute
• CAPA: Corrective and Preventive Actions

7) Documents, if any

• Production Records
• QC Testing Results
• Stability Study Reports
• Complaints and Deviation Reports
• Regulatory Submissions

8) Reference, if any

• ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
• EMA Guideline on Annual Product Quality Review
• Company-specific APR procedures and guidelines

9) SOP Version

Version 1.0