Defining Selection Criteria for Analytical Method Development

1) Purpose

The purpose of this SOP is to establish criteria for selecting the most appropriate analytical methods during the method development phase, ensuring that methods chosen meet the required standards of accuracy, precision, and robustness.

2) Scope

This SOP applies to all personnel involved in the selection of analytical methods during 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 establishing and applying method selection criteria.

4) Procedure

1. Define Method Requirements:
   1. Identify the specific requirements and objectives of the analytical method development project.
   2. Consider factors such as sample matrix, analyte properties, detection limits, and regulatory guidelines.
2. Selection Criteria Development:
   1. Develop criteria for evaluating potential analytical methods.
   2. Include parameters such as accuracy, precision, sensitivity, specificity, robustness, and ease of use.
3. Evaluation Process:
   1. Evaluate each method candidate against the established selection criteria.
   2. Use experimental data and scientific principles to assess method performance.
4. Decision Making:
   1. Make informed decisions based on the evaluation results to select the most suitable analytical method(s).
   2. Document the rationale for method selection decisions.
5. Documentation:
   1. Document the method selection criteria, evaluation process, and final decisions.
   2. Maintain records of all meetings and communications related to method selection.

5) Abbreviations, if any

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

6) Documents, if any

List of documents to be maintained related to this SOP:

• Method Requirements Document
• Selection Criteria Matrix
• Evaluation Reports for Method Candidates
• Method Selection Rationale
• Meeting Minutes

7) Reference, if any

Regulatory guidelines related to this SOP include:

• ICH Q2(R1): Validation of Analytical Procedures
• FDA Guidance for Industry: Analytical Procedures and Methods Validation

8) SOP Version

Version 1.0