Conducting a Literature Review for Formulation Development

1) Purpose

The purpose of this SOP is to provide a systematic procedure for conducting a literature review during the formulation development process to gather relevant scientific information, identify gaps, and inform the development strategy.

2) Scope

This SOP applies to all formulation development projects, ensuring a thorough and comprehensive literature review is conducted to support the project.

3) Responsibilities

The responsibilities for this SOP include:
Project Manager: Overseeing the literature review process and ensuring the review is comprehensive and relevant.
Team Members: Conducting the literature search, analyzing findings, and compiling the literature review report.
Quality Assurance: Reviewing and approving the final literature review report.

4) Procedure

4.1 Planning the Literature Review

1. Define the objectives and scope of the literature review.
2. Identify key topics, questions, and keywords for the literature search.
3. Document the literature review plan.

4.2 Conducting the Literature Search

1. Select appropriate databases and sources for the literature search (e.g., PubMed, Scopus, industry journals).
2. Perform the literature search using predefined keywords and criteria.
3. Document all sources and search results.

4.3 Screening and Selecting Relevant Literature

1. Screen the search results to identify relevant studies and articles.
2. Exclude irrelevant or low-quality sources based on predefined criteria.
3. Compile a list of selected literature for detailed review.

4.4 Analyzing and Summarizing Findings

1. Review and analyze the selected literature to extract key findings and data.
2. Summarize the findings in a structured format, highlighting important insights and trends.
3. Identify gaps in the existing literature and potential areas for further research.

4.5 Compiling the Literature Review Report

1. Compile the findings into a comprehensive literature review report.
2. Include sections on objectives, methodology, findings, gaps, and conclusions.
3. Review the draft report with team members and stakeholders for feedback.

4.6 Finalizing and Approving the Report

1. Incorporate feedback and finalize the literature review report.
2. Submit the final report to quality assurance for review and approval.
3. Distribute the approved report to all relevant stakeholders.

5) Abbreviations, if any

SOP: Standard Operating Procedure

6) Documents, if any

Literature Review Plan
Search Results Documentation
Literature Review Report

7) Reference, if any

– ICH Q10: Pharmaceutical Quality System
– FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations

8) SOP Version

Version 1.0