StabilityStudies.in
Standard Operating Procedure for Stability Testing in Compliance with EMA Guidelines
1) Purpose
The purpose of this SOP is to outline a procedure for conducting stability studies in compliance with the European Medicines Agency (EMA) guidelines to ensure that drug substances and products maintain their safety, quality, and efficacy.
2) Scope
This SOP applies to all drug substances and products requiring stability testing according to EMA 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 according to EMA guidelines.
- Quality Assurance (QA) Team: Reviews
and approves stability protocols and reports.
Regulatory Affairs Team: Ensures data is formatted for EMA submissions.
4) Procedure
- Preparation of Stability Protocol
- Develop a protocol that aligns with EMA stability testing requirements, including storage conditions, test intervals, and analytical methods.
- Submit the protocol for review and approval to the QA team.
- Execution of Stability Studies
- Store samples under specified conditions (e.g., 25°C/60% RH, 30°C/65% RH) in designated stability chambers.
- Conduct tests at each defined interval to evaluate stability parameters.
- Document all test results, observations, and any deviations from the protocol.
- Data Analysis and Submission
- Analyze data to ensure compliance with EMA stability requirements.
- Prepare a comprehensive report for submission to the EMA.
5) Abbreviations, if any
- QC: Quality Control
- QA: Quality Assurance
- EMA: European Medicines Agency
- RH: Relative Humidity
6) Documents, if any
- Stability Study Protocol
- Analytical Test Reports
- Stability Study Report
7) Reference, if any
- EMA Guideline on Stability Testing: Stability Testing of Existing Active Substances and Related Finished Products
8) SOP Version
Version 1.0
StabilityStudies.in