Selecting a Strategy for Analytical Method Development

1) Purpose

The purpose of this SOP is to describe the process for selecting the most appropriate strategy for analytical method development, ensuring that the chosen approach is suitable for the specific analytical needs and complies with regulatory requirements.

2) Scope

This SOP applies to all personnel involved in the strategy selection 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 the selection of the analytical method development strategy.

4) Procedure

1. Requirement Analysis:
   1. Conduct a thorough analysis of the analytical requirements based on the project objectives.
   2. Review the regulatory requirements and guidelines relevant to the project.
2. Strategy Options Identification:
   1. Identify potential strategies for analytical method development.
   2. Consider various approaches such as chromatographic methods, spectroscopic methods, and titration methods.
3. Feasibility Assessment:
   1. Assess the feasibility of each identified strategy in terms of resources, time, and cost.
   2. Evaluate the technical feasibility and potential challenges of each strategy.
4. Selection Criteria Development:
   1. Develop criteria for selecting the most appropriate strategy based on the project requirements and feasibility assessments.
   2. Include factors such as accuracy, precision, sensitivity, and specificity in the selection criteria.
5. Strategy Selection:
   1. Review all potential strategies against the developed selection criteria.
   2. Select the strategy that best meets the project requirements and feasibility assessments.
6. Documentation:
   1. Document the strategy selection process, including the requirement analysis, feasibility assessments, selection criteria, and final decision.
   2. Maintain records of all meetings and communications related to strategy selection.

5) Abbreviations, if any

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

6) Documents, if any

List of documents to be maintained related to this SOP:

• Requirement Analysis Report
• Feasibility Assessment Report
• Selection Criteria Document
• Meeting Minutes

7) Reference, if any

Regulatory guidelines related to this SOP include:

• ICH Q8: Pharmaceutical Development
• ICH Q9: Quality Risk Management

8) SOP Version

Version 1.0