Standard Operating Procedure for Stability Testing Following WHO Guidelines
1) Purpose
The purpose of this SOP is to establish a procedure for conducting stability testing in compliance with the World Health Organization (WHO) guidelines to ensure the safety, efficacy, and quality of pharmaceutical products.
2) Scope
This SOP applies to all drug substances and products that require stability testing as per WHO guidelines, including those intended for global distribution. It is relevant to departments involved in production, quality control, quality assurance, and regulatory compliance.
3) Responsibilities
- Quality Control (QC) Team: Performs stability testing according to WHO guidelines.
- Quality Assurance (QA) Team: Reviews and approves stability protocols and reports, ensuring WHO compliance.
- Regulatory Affairs Team: Ensures that the stability data meets WHO submission requirements.
4) Procedure
- Preparation of Stability Protocol
- Draft a protocol outlining storage conditions, test intervals, and analytical methods in line with WHO guidelines.
- Submit the protocol for review and approval to the QA team.
- Execution of Stability Study
- Store samples in designated chambers under specified conditions (e.g., 30°C/65% RH).
- Conduct tests at each interval to evaluate parameters such as potency, degradation, and microbiological stability.
- Document all test results, observations, and deviations from the protocol.
- Data Analysis and Submission
- Analyze data to ensure compliance with WHO stability requirements.
- Prepare a comprehensive report for submission to the relevant regulatory body.
5) Abbreviations, if any
- QC: Quality Control
- QA: Quality Assurance
- WHO: World Health Organization
- RH: Relative Humidity
6) Documents, if any
- Stability Study Protocol
- Analytical Test Reports
- Stability Study Report
7) Reference, if any
- WHO Guidelines for Stability Testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products
8) SOP Version
Version 1.0