StabilityStudies.in
Standard Operating Procedure for Stability Testing of Drug Implants
1) Purpose
The purpose of this SOP is to establish a standardized procedure for conducting stability studies on drug implants to ensure their safety, efficacy, and controlled release characteristics are maintained throughout their shelf life.
2) Scope
This SOP applies to all drug implants manufactured, tested, or stored within the facility. It is relevant to departments involved in production, quality control, quality assurance, and regulatory compliance.
3) Responsibilities
- Quality Control (QC) Team: Conducts stability testing, including in vitro release testing, mechanical strength, and sterility tests.
- Quality Assurance (QA) Team: Reviews and
approves the stability study protocols and final reports.
Production Team: Provides necessary samples and maintains production records.
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4) Procedure
- Sample Preparation
- Collect representative samples of drug implants from production batches.
- Store samples under appropriate conditions until stability testing begins.
- Development of Stability Study Protocol
- Store samples in designated stability chambers under specified conditions (e.g., 25°C/60% RH, 40°C/75% RH).
- Perform tests at each interval to assess the implant’s stability, release characteristics, and sterility.
- Document all test results, observations, and any deviations from the protocol.
- Analyze the stability data to determine whether the drug implant meets predefined acceptance criteria over time.
- Prepare a detailed stability study report and submit it to the QA team for review and approval.
5) Abbreviations, if any
- QC: Quality Control
- QA: Quality Assurance
- RH: Relative Humidity
6) Documents, if any
- Stability Study Protocol
- Analytical Test Reports
- Stability Study Report
7) Reference, if any
- ICH Q1A(R2): Stability Testing of New Drug Substances and Products
- FDA Guidance for Industry: Quality System Regulation for Medical Devices
8) SOP Version
Version 1.0