Conducting Feasibility Studies for Analytical Method Development

1) Purpose

The purpose of this SOP is to describe the procedure for conducting feasibility studies as part of the analytical method development process, ensuring that potential methods are evaluated for their practicality and effectiveness.

2) Scope

This SOP applies to all personnel involved in conducting feasibility 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 the feasibility studies for analytical method development.

4) Procedure

1. Identify Method Candidates:
   1. Identify potential analytical methods that meet the project requirements.
   2. Consider methods identified during the literature review and previous experiences.
2. Define Evaluation Criteria:
   1. Establish criteria for evaluating the feasibility of each method candidate.
   2. Include factors such as accuracy, precision, sensitivity, specificity, and robustness.
3. Conduct Preliminary Experiments:
   1. Perform preliminary experiments to assess the feasibility of each method candidate.
   2. Collect data on the performance of each method under defined conditions.
4. Analyze Data:
   1. Analyze the data collected from the preliminary experiments.
   2. Compare the results against the established evaluation criteria.
5. Select Feasible Methods:
   1. Select the methods that meet the evaluation criteria and show potential for further development.
   2. Document the rationale for the selection of feasible methods.
6. Documentation:
   1. Document the feasibility study process, including method candidates, evaluation criteria, experimental data, and selection decisions.
   2. Maintain records of all feasibility study meetings and communications.

5) Abbreviations, if any

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

6) Documents, if any

List of documents to be maintained related to this SOP:

• Feasibility Study Plan
• Evaluation Criteria Document
• Preliminary Experiment Data
• Feasibility Study Report
• Meeting Minutes

7) Reference, if any

Regulatory guidelines related to this SOP include:

• ICH Q8: Pharmaceutical Development
• FDA Guidance for Industry: Analytical Procedures and Methods Validation

8) SOP Version

Version 1.0