Standard Operating Procedure for Stability Testing of Combination Products
1) Purpose
The purpose of this SOP is to establish a procedure for designing stability studies for combination products, such as drug-device combinations, in compliance with applicable regulatory guidelines to ensure their safety, efficacy, and quality over their shelf life.
2) Scope
This SOP applies to all combination products requiring stability studies as per regulatory 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 as per the designed study.
- Quality Assurance
(QA) Team: Reviews and approves stability protocols and reports.
Regulatory Affairs Team: Ensures compliance with applicable guidelines for combination products.
4) Procedure
- Study Design Development
- Draft a stability study protocol for combination products, specifying storage conditions, test intervals, and analytical methods.
- Ensure the protocol meets applicable regulatory requirements for both the drug and device components.
- Submit the protocol for review and approval by the QA team.
- Execution of Stability Studies
- Store samples in designated chambers under specified conditions.
- Conduct tests at each interval to assess the stability of both the drug and device components.
- Document all test results, observations, and deviations from the protocol.
- Data Analysis and Reporting
- Analyze data to ensure compliance with regulatory requirements for combination products.
- Prepare a stability study report and submit it to the QA and Regulatory Affairs teams for review and approval.
5) Abbreviations, if any
- QC: Quality Control
- QA: Quality Assurance
6) Documents, if any
- Stability Study Protocol
- Analytical Test Reports
- Stability Study Report
7) Reference, if any
- FDA Guidance for Industry: Current Good Manufacturing Practice Requirements for Combination Products
8) SOP Version
Version 1.0