Managing Method Lifecycle for Analytical Method Development

1) Purpose

The purpose of this SOP is to outline the procedure for managing the lifecycle of analytical methods developed within the analytical development department, ensuring ongoing method performance and compliance.

2) Scope

This SOP applies to all personnel involved in managing the lifecycle of analytical methods for 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 managing the lifecycle of analytical methods.

4) Procedure

1. Method Performance Monitoring:
   1. Establish a schedule for monitoring the performance of developed analytical methods.
   2. Define criteria for assessing method performance parameters such as accuracy, precision, specificity, and robustness.
2. Periodic Review:
   1. Conduct periodic reviews of analytical methods based on predefined intervals or trigger events.
   2. Evaluate method performance data to identify trends, deviations, or opportunities for improvement.
3. Method Optimization:
   1. Initiate method optimization activities as necessary to address identified performance issues or to improve method efficiency.
   2. Document all optimization activities and changes made to analytical methods.
4. Method Revalidation:
   1. Plan and execute revalidation of analytical methods following significant changes or at predefined intervals.
   2. Ensure compliance with validation requirements and document revalidation activities.
5. Documentation and Reporting:
   1. Document all lifecycle management activities, including method performance monitoring, reviews, optimizations, and revalidations.
   2. Prepare periodic reports summarizing method lifecycle management activities and outcomes.
6. Review and Approval:
   1. Review lifecycle management reports for accuracy, completeness, and compliance with departmental procedures.
   2. Obtain necessary approvals from stakeholders before finalizing lifecycle management reports.

5) Abbreviations, if any

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

6) Documents, if any

List of documents to be maintained related to this SOP:

• Method Performance Monitoring Records
• Periodic Review Reports
• Method Optimization Documentation
• Revalidation Records
• Lifecycle Management Reports

7) Reference, if any

Regulatory guidelines related to this SOP include:

• ICH Q2(R1): Validation of Analytical Procedures
• USP General Chapter Validation of Compendial Procedures

8) SOP Version

Version 1.0