Standard Operating Procedure for Stability Testing of Modified Release Products

1) Purpose

The purpose of this SOP is to provide a standardized approach for conducting stability studies for modified-release products in compliance with US FDA and ICH guidelines to ensure their safety, quality, and efficacy throughout their shelf life.

2) Scope

This SOP applies to all modified-release products that require stability testing under FDA and ICH guidelines. It is relevant to departments involved in production, quality control, quality assurance, and regulatory compliance.

3) Responsibilities

• Quality Control (QC) Team: Conducts stability testing as per protocol.
• Quality Assurance (QA) Team: Reviews and approves stability protocols and reports.
• Regulatory Affairs Team: Ensures stability data meets submission requirements.

4) Procedure

1. Preparation of Stability Protocol
   1. Draft a stability study protocol detailing storage conditions, test intervals, and analytical methods.
   2. Ensure the protocol is compliant with FDA and ICH guidelines.
   3. Submit the protocol for review and
      

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      approval by the QA team.
2. Execution of Stability Studies
   1. Store samples in designated chambers under specified conditions (e.g., 25°C/60% RH, 30°C/65% RH).
   2. Conduct tests at each interval to assess stability parameters specific to modified-release formulations, such as dissolution and drug release profiles.
   3. Document all observations, test results, and any deviations from the protocol.
3. Data Analysis and Reporting
   1. Analyze data to ensure compliance with FDA and ICH guidelines for modified-release products.
   2. Prepare a comprehensive stability study report for submission.

5) Abbreviations, if any

• QC: Quality Control
• QA: Quality Assurance
• ICH: International Council for Harmonisation
• FDA: Food and Drug Administration
• RH: Relative Humidity

6) Documents, if any

• Stability Study Protocol
• Analytical Test Reports
• Stability Study Report

7) Reference, if any

• FDA Guidance for Industry: Extended Release and Long-Acting Products
• ICH Q1A(R2): Stability Testing of New Drug Substances and Products

8) SOP Version

Version 1.0