Standard Operating Procedure for Stability Testing of IV Products
1) Purpose
The purpose of this SOP is to define procedures for conducting stability testing on intravenous (IV) products to evaluate their physical, chemical, and microbiological stability under various storage conditions.
2) Scope
This SOP applies to all personnel involved in conducting and overseeing stability testing of IV products within the pharmaceutical manufacturing facility.
3) Responsibilities
3.1 Quality Control (QC) Team
- Plan and conduct stability studies as per regulatory requirements.
- Analyze stability data and interpret results.
3.2 Manufacturing and Research & Development (R&D) Teams
- Provide stability samples as per defined schedules.
- Review and approve stability protocols and reports.
4) Procedure
4.1 Stability Study Design
- Define stability testing parameters including storage conditions and duration.
- Prepare stability study protocols outlining sampling plan and testing procedures.
4.2 Sample Collection and Storage
- Collect stability samples representative of commercial batches.
- Label and store samples under specified conditions (e.g., temperature, humidity).
4.3 Stability Testing
- Perform physical, chemical, and microbiological tests at defined time points.
- Record and analyze stability data including degradation trends and shelf-life estimation.
4.4 Stability Report Preparation
- Compile stability data and prepare comprehensive stability reports.
- Summarize results, conclusions, and recommendations for product shelf-life.
5) Abbreviations, if any
SOP: Standard Operating Procedure; IV: Intravenous; QC: Quality Control; R&D: Research & Development
6) Documents, if any
- Stability Study Protocols
- Stability Testing Reports
- Shelf-life Estimation Records
7) Reference, if any
ICH Q1A(R2): Stability Testing of New Drug Substances and Products
FDA Guidance for Industry: Stability Testing of Drug Substances and Drug Products
8) SOP Version
Version 1.0