Conducting Literature Review for Analytical Method Development

1) Purpose

The purpose of this SOP is to describe the procedure for conducting a comprehensive literature review as part of the analytical method development process, ensuring that all relevant scientific and regulatory information is gathered and reviewed.

2) Scope

This SOP applies to all personnel involved in conducting literature reviews 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 literature review process for analytical method development.

4) Procedure

1. Define Objectives:
   1. Clearly define the objectives of the literature review based on the analytical method development project requirements.
2. Identify Sources:
   1. Identify relevant sources of information, including scientific journals, books, regulatory guidelines, and online databases.
3. Conduct Search:
   1. Perform a systematic search using identified sources to gather relevant literature.
   2. Use appropriate keywords and search strategies to ensure comprehensive coverage.
4. Review and Evaluate:
   1. Review the gathered literature for relevance, quality, and completeness.
   2. Evaluate the findings in the context of the analytical method development project.
5. Summarize Findings:
   1. Summarize the key findings from the literature review, highlighting relevant information and gaps in knowledge.
6. Documentation:
   1. Document the literature review process, including search strategies, sources, and findings.
   2. Maintain records of all reviewed literature and the evaluation criteria used.

5) Abbreviations, if any

The purpose of this SOP is to define the commonly used abbreviations related to the literature review process for analytical method development.

6) Documents, if any

List of documents to be maintained related to this SOP:

• Literature Review Plan
• Search Strategy Documentation
• Literature Evaluation Criteria
• Summary of Findings
• 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