Standard Operating Procedure for Creating a Stability-Indicating Method Following ICH Q2(R1)
1) Purpose
The purpose of this SOP is to provide a standardized procedure for developing a stability-indicating analytical method that complies with ICH Q2(R1) guidelines to ensure the accuracy, precision, and reliability of stability testing.
2) Scope
This SOP applies to all analytical methods developed for stability testing of drug substances and products. It is relevant to departments involved in quality control, quality assurance, and regulatory affairs.
3) Responsibilities
- Analytical Development Team: Develops and validates the stability-indicating method.
- Quality Assurance (QA) Team: Reviews and approves the
method development and validation reports.
Quality Control (QC) Team: Uses the validated method for routine stability testing.
4) Procedure
- Method Development
- Select the appropriate analytical techniques (e.g., HPLC, GC, UV) for the stability-indicating method.
- Develop a method that can accurately separate and quantify the drug substance and its degradation products.
- Method Validation
- Validate the method according to ICH Q2(R1) guidelines for parameters such as specificity, accuracy, precision, linearity, range, and robustness.
- Document all validation data and submit it for review by the QA team.
- Implementation and Monitoring
- Implement the validated method for routine stability testing.
- Monitor the method’s performance and make adjustments as necessary.
5) Abbreviations, if any
- HPLC: High-Performance Liquid Chromatography
- GC: Gas Chromatography
- UV: Ultraviolet Spectroscopy
- QC: Quality Control
- QA: Quality Assurance
- ICH: International Council for Harmonisation
6) Documents, if any
- Method Development Report
- Method Validation Report
- Routine Testing Records
7) Reference, if any
- ICH Q2(R1): Validation of Analytical Procedures: Text and Methodology
8) SOP Version
Version 1.0