method and ensure its robustness and accuracy.

Regulatory Affairs Team: To ensure the method meets regulatory requirements for stability testing.

Stability Study Coordinator: To manage method development, validation, and implementation processes.

4) Procedure

The detailed stepwise procedure for establishing a stability-indicating method is

outlined below:

1. Method Development:
1. 4.1 Define the purpose, scope, and objective of the stability-indicating method.
2. 4.2 Identify the drug substance or product and the critical quality attributes (CQAs) to be monitored.
3. 4.3 Select an appropriate analytical technique (e.g., HPLC, GC, LC-MS) for the method development.
4. 4.4 Develop the method by optimizing parameters such as mobile phase, column type, flow rate, and detection wavelength.
5. 4.5 Conduct preliminary experiments to assess the method’s ability to separate degradation products from the active ingredient.
2. Method Validation:
1. 4.6 Validate the method according to ICH guidelines for parameters like specificity, accuracy, precision, linearity, range, and robustness.
2. 4.7 Perform forced degradation studies to confirm the method’s ability to indicate stability and detect degradation products.
3. 4.8 Document all validation experiments, data, and results in a validation report.
3. Method Implementation:
1. 4.9 Implement the validated method in routine stability testing.
2. 4.10 Train relevant personnel on the use of the method and ensure compliance with standard procedures.
3. 4.11 Monitor the method’s performance during routine use and make adjustments if necessary.
4. Documentation and Reporting:
1. 4.12 Compile a comprehensive report on method development, validation, and implementation, including objectives, methods, results, and conclusions.
2. 4.13 Ensure the report is reviewed and approved by relevant stakeholders.
3. 4.14 Submit the report to regulatory bodies or internal stakeholders as required.
5. Review and Update:
1. 4.15 Regularly review the stability-indicating method and update it based on new data or regulatory changes.
2. 4.16 Archive the approved method development and validation report in a controlled document management system.

5) Abbreviations, if any

• HPLC: High-Performance Liquid Chromatography
• GC: Gas Chromatography
• LC-MS: Liquid Chromatography-Mass Spectrometry
• CQA: Critical Quality Attribute

6) Documents, if any

• Stability-Indicating Method Validation Report
• Method Development and Validation Protocol
• Analytical Method Transfer Report

7) Reference, if any

• ICH Q2(R1): Validation of Analytical Procedures

8) SOP Version

Version 1.0