Standard Operating Procedure for Conducting Stability Studies Under US FDA CFR Title 21
1) Purpose
The purpose of this SOP is to provide a standardized approach for conducting stability studies for drug products in compliance with US FDA CFR Title 21, ensuring that they meet the required quality standards over their shelf life.
2) Scope
This SOP applies to all drug products for which stability studies are conducted under US FDA regulations. 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 the protocol and FDA guidelines.
Quality Assurance (QA) Team: Reviews and approves stability protocols and reports.
Regulatory Affairs Team: Ensures compliance with US FDA requirements for stability testing.
4) Procedure
- Preparation of Stability Protocol
- Draft a protocol detailing storage conditions, test intervals, and analytical methods per US FDA CFR Title 21.
- Submit the protocol for review and approval to the QA team.
- Draft a protocol detailing storage conditions, test
- Execution of Stability Study
- Store samples in designated stability chambers under specified conditions (e.g., 25°C/60% RH, 40°C/75% RH).
- Conduct analytical tests at each specified interval to assess stability parameters.
- Record all observations, test results, and any deviations from the protocol.
- Data Analysis and Reporting
- Analyze data to ensure compliance with US FDA requirements.
- Prepare a stability study report for submission to the relevant regulatory body.
5) Abbreviations, if any
- QC: Quality Control
- QA: Quality Assurance
- FDA: Food and Drug Administration
- CFR: Code of Federal Regulations
- RH: Relative Humidity
6) Documents, if any
- Stability Study Protocol
- Analytical Test Reports
- Stability Study Report
7) Reference, if any
- US FDA CFR Title 21 Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals
8) SOP Version
Version 1.0