Standard Operating Procedure for Stability Testing of New Dosage Forms as per ICH Q1C
1) Purpose
The purpose of this SOP is to provide a standardized procedure for conducting stability testing of new dosage forms in compliance with ICH Q1C guidelines to ensure their quality, safety, and efficacy over their intended shelf life.
2) Scope
This SOP applies to all new dosage forms that require stability testing under ICH Q1C guidelines. It is relevant to departments involved in production, quality control, quality assurance, and regulatory affairs.
3) Responsibilities
- Quality Control (QC) Team: Conducts stability
testing in compliance with ICH Q1C guidelines.
Quality Assurance (QA) Team: Reviews and approves stability protocols and reports.
Regulatory Affairs Team: Ensures stability data meets submission requirements.
4) Procedure
- Preparation of Stability Protocol
- Draft a stability study protocol for the new dosage form, specifying storage conditions, test intervals, and analytical methods.
- Ensure the protocol complies with ICH Q1C guidelines.
- Submit the protocol for review and approval by the QA team.
- Draft a stability study protocol for the new dosage form, specifying storage conditions, test intervals,
- Execution of Stability Studies
- Store samples in stability chambers under specified conditions.
- Conduct tests at defined intervals to assess stability parameters specific to the new dosage form.
- Document all test results, observations, and any deviations from the protocol.
- Data Analysis and Reporting
- Analyze data to ensure compliance with ICH Q1C requirements.
- Prepare a comprehensive stability study report for submission to the regulatory authorities.
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 Q1C: Stability Testing of New Dosage Forms
8) SOP Version
Version 1.0