and supported by existing knowledge.

2. Scope

This SOP is applicable to all Analytical Method Development (AMD) personnel involved in the planning, development, and optimization of analytical methods for APIs, excipients, intermediates, and finished pharmaceutical products.

3. Responsibilities

• Analytical Scientist: Conducts the literature review using approved scientific databases and documents findings in the predefined format.
• AMD Team Lead: Reviews the literature summary and ensures its relevance and quality before including it in the method development protocol.
• QA Department: Ensures compliance with documentation standards and reviews bibliographic references.
• HOD – AMD: Approves the final literature review summary for incorporation into regulatory or internal documentation.

4. Accountability

The Head of the Analytical Method Development department is accountable for ensuring that a valid, comprehensive, and documented literature review is conducted for each analytical method under development.

5. Procedure

5.1 Planning the Literature Review

1. Initiate the literature review at the feasibility stage of method development.
2. Define objectives of the review (e.g., identifying existing methods, optimization techniques, chromatographic conditions, detection systems).
3. Use the Literature Review Plan template (Annexure-1) to define search goals.

5.2 Selection of Databases and Resources

1. Use validated and reputed scientific databases, such as:
   • PubMed
   • ScienceDirect
   • Google Scholar
   • Journals (e.g., Journal of Chromatography, Analytical Chemistry)
   • Pharmacopoeias (IP, USP, BP, Ph.Eur, JP)
   • Patent databases (WIPO, USPTO, Espacenet)
2. Document search sources in Annexure-2: Reference Log.

5.3 Search Strategy and Execution

1. Use specific and relevant keywords such as:
   • “HPLC method for [API Name]”
   • “Analytical validation [Drug Name]”
   • “Stability indicating method development”
2. Apply Boolean operators and filters for recent publications (last 10 years preferred).
3. Save all relevant articles and references in digital format in the project folder.

5.4 Data Extraction and Compilation

1. Extract the following information for each relevant article or method:
   • Author(s), title, journal, year
   • Chromatographic system (column, mobile phase, pH, flow rate)
   • Sample preparation technique
   • Validation data (specificity, LOD, LOQ, linearity, accuracy, precision)
2. Enter findings into Annexure-3: Literature Summary Table.

5.5 Analysis and Selection of Suitable Approach

1. Compare extracted data for consistency, regulatory compliance, and analytical performance.
2. Select appropriate strategies for method design based on:
   • Robustness and reproducibility
   • Ease of execution
   • Alignment with pharmacopoeial or published standards

5.6 Documentation and Review

1. Prepare a final report summarizing:
   • Databases used
   • Number of articles shortlisted
   • Summary of findings
   • Proposed approach for method development
2. Review and approval by AMD Team Lead and QA before filing into the method development protocol file.
3. Ensure all documentation is retained as per GMP record retention policy.

6. Abbreviations

• AMD: Analytical Method Development
• QA: Quality Assurance
• API: Active Pharmaceutical Ingredient
• LOD: Limit of Detection
• LOQ: Limit of Quantitation
• SOP: Standard Operating Procedure

7. Documents

1. Literature Review Plan – Annexure-1
2. Reference Log – Annexure-2
3. Literature Summary Table – Annexure-3

8. References

• ICH Q8 – Pharmaceutical Development
• ICH Q2(R1) – Validation of Analytical Procedures
• WHO TRS 996 – Annex on Analytical Methodology
• Scientific Journals, Pharmacopoeias, Patents

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Literature Review Plan

Product	Review Objective	Date Initiated	Initiated By
Amlodipine Tablets	Identify existing HPLC assay methods	10/04/2025	Ajay Verma

Annexure-2: Reference Log

Source	Search Term	Date Accessed	Reviewed By
PubMed	Amlodipine HPLC	12/04/2025	Sunita Reddy
ScienceDirect	Stability method Amlodipine	13/04/2025	Rajesh Kumar

Annexure-3: Literature Summary Table

Title	Journal	Year	Column Used	Detection	Notes
RP-HPLC method for Amlodipine	J Chrom Sci	2021	C18, 250mm	UV at 238nm	Used phosphate buffer:methanol

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
04/05/2025	2.0	Introduced structured annexures and search tracking table	Regulatory alignment