Standard Operating Procedure for Stability Testing Following Post-Approval Changes

1) Purpose

The purpose of this SOP is to provide a standardized approach for managing stability testing following post-approval changes to drug substances and products in compliance with US FDA guidelines.

2) Scope

This SOP applies to all stability studies required following post-approval changes, such as formulation, manufacturing process, packaging, or storage conditions, for drug substances and products. It is relevant to departments involved in quality control, quality assurance, regulatory affairs, and production.

3) Responsibilities

• Quality Control (QC) Team: Conducts stability testing as per the revised protocol.
• Quality Assurance (QA) Team: Reviews and approves protocols and stability study results following post-approval changes.
• Regulatory Affairs Team: Ensures all stability data related to post-approval changes comply with US FDA requirements.

4) Procedure

1. Development of Revised Stability Protocol
   1. Draft a revised stability study protocol to account for the post-approval changes, detailing storage
      

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      conditions, test intervals, and analytical methods.
   2. Submit the revised protocol for review and approval by the QA team.
2. Execution of Stability Studies
   1. Store samples under conditions specified in the revised protocol.
   2. Conduct analytical tests at each interval to assess the impact of post-approval changes on stability parameters.
   3. Document all test results, observations, and deviations from the revised protocol.
3. Data Analysis and Reporting
   1. Analyze stability data to ensure compliance with FDA requirements following post-approval changes.
   2. Prepare a comprehensive stability study report for submission to the FDA, detailing the impact of post-approval changes.

5) Abbreviations, if any

• QC: Quality Control
• QA: Quality Assurance
• FDA: Food and Drug Administration

6) Documents, if any

• Revised Stability Study Protocol
• Analytical Test Reports
• Stability Study Report for Post-Approval Changes

7) Reference, if any

• FDA Guidance for Industry: Changes to an Approved NDA or ANDA

8) SOP Version

Version 1.0