Conducting Forced Degradation Studies for Analytical Method Development

1) Purpose

The purpose of this SOP is to outline the procedure for conducting forced degradation studies during the analytical method development process, aimed at evaluating method specificity and stability indicating capability.

2) Scope

This SOP applies to all personnel involved in conducting forced degradation studies for analytical method development projects within the analytical development department.

3) Responsibilities

The purpose of this SOP is to define the roles and responsibilities of all personnel involved in conducting forced degradation studies.

4) Procedure

1. Study Design:
   1. Define the objectives and scope of the forced degradation study based on regulatory requirements and product stability characteristics.
   2. Identify stress conditions (e.g., temperature, humidity, light exposure) based on product properties.
2. Sample Preparation:
   1. Prepare test samples according to predefined stress conditions and durations.
   2. Document sample preparation details, including concentrations and storage conditions.
3. Stress Testing:
   1. Expose test samples to stress conditions as per the study design.
   2. Monitor degradation over time and document observations.
4. Analysis of Degradation Products:
   1. Analyze degraded samples using developed analytical methods to detect and quantify degradation products.
   2. Evaluate method specificity and stability indicating capability based on degradation product profiles.
5. Documentation and Reporting:
   1. Document all forced degradation study activities, including study design, sample preparation, stress testing, analysis, and results interpretation.
   2. Prepare a forced degradation study report summarizing study objectives, methods, results, and conclusions.
6. Review and Approval:
   1. Review the forced degradation study report for accuracy, completeness, and compliance with protocol requirements.
   2. Obtain necessary approvals from stakeholders before finalizing the forced degradation study report.

5) Abbreviations, if any

The purpose of this SOP is to define the commonly used abbreviations related to forced degradation studies for analytical method development.

6) Documents, if any

List of documents to be maintained related to this SOP:

• Forced Degradation Study Report
• Sample Preparation Records
• Stress Testing Data
• Degradation Product Analysis Results
• Review and Approval Records

7) Reference, if any

Regulatory guidelines related to this SOP include:

• ICH Q1A(R2): Stability Testing of New Drug Substances and Products
• ICH Q2(R1): Validation of Analytical Procedures

8) SOP Version

Version 1.0