Standard Operating Procedure for Stability Testing of Biologics According to FDA Guidelines
1) Purpose
The purpose of this SOP is to provide a standardized procedure for conducting stability studies on biologic drug products in compliance with US FDA guidelines, ensuring the product’s safety, potency, and efficacy throughout its shelf life.
2) Scope
This SOP applies to all biologic drug products requiring stability testing per FDA 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 using appropriate methods for biologics.
- Quality Assurance (QA)
Team: Reviews and approves stability protocols and reports.
Regulatory Affairs Team: Ensures stability data meets FDA submission requirements for biologics.
4) Procedure
- Development of Stability Protocol
- Prepare a protocol detailing storage conditions (e.g., refrigerated, frozen), test intervals, and analytical methods specific to biologics.
- Submit the protocol for review and approval to the QA team.
- Execution of Stability Study
- Store samples under specified conditions (e.g., 2-8°C, -20°C) in designated stability chambers.
- Perform tests at each interval to evaluate stability parameters such as potency, purity, and sterility.
- Record all observations, test results, and any deviations from the protocol.
- Data Analysis and Reporting
- Analyze data to ensure compliance with FDA requirements for biologics.
- Prepare a comprehensive report for submission to the FDA.
5) Abbreviations, if any
- QC: Quality Control
- QA: Quality Assurance
- FDA: Food and Drug Administration
6) Documents, if any
- Stability Study Protocol
- Analytical Test Reports
- Stability Study Report
7) Reference, if any
- FDA Guidance for Industry: Stability Testing of Biotechnological/Biological Products
8) SOP Version
Version 1.0