Conducting Phase I Screening for Analytical Method Development

1) Purpose

The purpose of this SOP is to outline the procedure for conducting Phase I screening during the method development process, aiming to identify initial method candidates for further optimization.

2) Scope

This SOP applies to all personnel involved in Phase I screening 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 Phase I screening for analytical method development.

4) Procedure

1. Method Selection:
   1. Based on pre-screening studies, select method candidates to undergo Phase I screening.
   2. Consider factors such as initial performance, simplicity, and feasibility for further development.
2. Experimental Design:
   1. Design experiments to evaluate the selected method candidates under defined conditions.
   2. Define experimental parameters, acceptance criteria, and data collection methods.
3. Method Evaluation:
   1. Conduct experiments according to the designed plan to assess method performance.
   2. Collect and analyze data to evaluate criteria such as accuracy, precision, and sensitivity.
4. Data Interpretation:
   1. Interpret experimental results to identify potential method candidates showing promise.
   2. Document observations and initial conclusions for each method evaluated.
5. Selection Decision:
   1. Based on Phase I screening results, decide which methods should proceed to Phase II optimization.
   2. Document the rationale for selecting or excluding method candidates.
6. Documentation:
   1. Document the Phase I screening process, including method selection, experimental design, evaluation, data interpretation, and selection decisions.
   2. Maintain records of all Phase I screening meetings and communications.

5) Abbreviations, if any

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

6) Documents, if any

List of documents to be maintained related to this SOP:

• Phase I Screening Plan
• Experimental Design Documentation
• Data Analysis Reports
• Phase I Screening Summary
• 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