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
- Define the objectives and scope of the literature review.
- Identify key topics, questions, and keywords for the literature search.
- Document the literature review plan.
4.2 Conducting the Literature Search
- Select appropriate databases and sources for the literature search (e.g., PubMed, Scopus, industry journals).
- Perform the literature search using predefined keywords and criteria.
- Document all sources and search results.
4.3 Screening and Selecting Relevant Literature
- Screen the search results to identify relevant studies and articles.
- Exclude irrelevant or low-quality sources based on predefined criteria.
- Compile a list of selected literature for detailed review.
4.4
- Review and analyze the selected literature to extract key findings and data.
- Summarize the findings in a structured format, highlighting important insights and trends.
- Identify gaps in the existing literature and potential areas for further research.
4.5 Compiling the Literature Review Report
- Compile the findings into a comprehensive literature review report.
- Include sections on objectives, methodology, findings, gaps, and conclusions.
- Review the draft report with team members and stakeholders for feedback.
4.6 Finalizing and Approving the Report
- Incorporate feedback and finalize the literature review report.
- Submit the final report to quality assurance for review and approval.
- 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
