Conducting Pre-screening Studies for Analytical Method Development

1) Purpose

The purpose of this SOP is to outline the procedure for conducting pre-screening studies to identify potential analytical methods for further development, ensuring efficient use of resources and time.

2) Scope

This SOP applies to all personnel involved in conducting pre-screening 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 pre-screening studies for analytical method development.

4) Procedure

1. Define Screening Criteria:
   1. Establish criteria for identifying potential analytical methods based on project requirements.
   2. Consider factors such as method suitability, simplicity, and initial performance indicators.
2. Method Identification:
   1. Identify candidate methods through literature review, internal knowledge, or previous experiences.
   2. Document the rationale for selecting each method candidate.
3. Experimental Setup:
   1. Design and set up experiments to evaluate the initial performance of selected method candidates.
   2. Define experimental parameters and acceptance criteria for screening.
4. Data Collection and Analysis:
   1. Collect data from pre-screening experiments and analyze method performance against defined criteria.
   2. Use statistical methods to assess initial method suitability and robustness.
5. Selection Decision:
   1. Based on pre-screening results, decide which methods show promise for further development.
   2. Document the rationale for selecting or excluding method candidates.
6. Documentation:
   1. Document the pre-screening study process, including screening criteria, method identification, experimental setup, data analysis, and selection decisions.
   2. Maintain records of all pre-screening study meetings and communications.

5) Abbreviations, if any

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

6) Documents, if any

List of documents to be maintained related to this SOP:

• Screening Criteria Document
• Method Identification Rationale
• Pre-screening Experiment Reports
• Method Selection Summary
• 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