Standard Operating Procedure for Stability Testing of Export Products Following ICH Q1F

1) Purpose

The purpose of this SOP is to provide a standardized procedure for conducting stability testing for drug products intended for export to markets covered by ICH Q1F guidelines to ensure compliance with international regulatory standards.

2) Scope

This SOP applies to all drug products intended for export to countries adhering to ICH Q1F 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 in accordance with ICH Q1F requirements.
• Quality Assurance (QA) Team: Reviews and approves protocols and final reports to ensure compliance.
• Regulatory Affairs Team: Prepares documentation for international submissions.

4) Procedure

1. Preparation of Stability Protocol
   1. Develop a protocol outlining storage conditions (e.g., climatic zone-specific conditions), test intervals, and analytical methods.
   2. Submit the protocol for review and approval to the
      

      “The Assurance of Safe and Effective Medications: Cutting-edge Methods for Pharmaceutical Stability Testing Unveiled”

      QA team.
2. Execution of Stability Study
   1. Store samples under specified conditions according to ICH Q1F guidelines.
   2. Conduct tests at defined intervals to evaluate critical quality attributes.
   3. Document all results, observations, and deviations from the protocol.
3. Data Analysis and Reporting
   1. Analyze stability data to ensure compliance with ICH Q1F standards.
   2. Prepare a comprehensive stability study report for international regulatory submissions.

5) Abbreviations, if any

• QC: Quality Control
• QA: Quality Assurance
• ICH: International Council for Harmonisation

6) Documents, if any

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

7) Reference, if any

• ICH Q1F: Stability Data Package for Registration Applications in Climatic Zones III and IV

8) SOP Version

Version 1.0