Developing Impurity Methods for Analytical Method Development

1) Purpose

The purpose of this SOP is to outline the procedure for developing impurity methods during the analytical method development process, ensuring accurate detection and quantification of impurities in pharmaceutical products.

2) Scope

This SOP applies to all personnel involved in developing impurity methods 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 developing impurity methods.

4) Procedure

1. Method Development Objectives:
   1. Define objectives for developing impurity methods based on regulatory requirements and product specifications.
   2. Identify target impurities and establish acceptance criteria.
2. Selection of Analytical Techniques:
   1. Evaluate and select appropriate analytical techniques (e.g., chromatography, spectroscopy) for impurity detection and quantification.
   2. Consider method sensitivity, specificity, and robustness.
3. Optimization of Method Parameters:
   1. Optimize method parameters such as mobile phase composition, column temperature, and detection wavelength.
   2. Conduct system suitability tests to ensure method performance meets predefined criteria.
4. Validation of Impurity Methods:
   1. Validate impurity methods according to regulatory guidelines and predefined acceptance criteria.
   2. Document validation results and conclusions regarding method suitability for impurity analysis.
5. Documentation and Reporting:
   1. Document all impurity method development activities, including method objectives, technique selection, optimization, and validation.
   2. Prepare an impurity method development report summarizing method development activities and outcomes.
6. Review and Approval:
   1. Review the impurity method development report for accuracy, completeness, and compliance with protocol requirements.
   2. Obtain necessary approvals from stakeholders before finalizing the impurity method development report.

5) Abbreviations, if any

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

6) Documents, if any

List of documents to be maintained related to this SOP:

• Impurity Method Development Report
• Validation Results Documentation
• System Suitability Test Records
• Review and Approval Records
• Meeting Minutes

7) Reference, if any

Regulatory guidelines related to this SOP include:

• ICH Q3A(R2): Impurities in New Drug Substances
• ICH Q2(R1): Validation of Analytical Procedures

8) SOP Version

Version 1.0