all AMD personnel responsible for developing or verifying analytical methods that are derived from or compared to official pharmacopoeial monographs, including those from IP, USP, BP, Ph.Eur, and JP.

3. Responsibilities

• AMD Analyst: Locates and retrieves the relevant pharmacopoeial monograph and performs comparative assessments with internal methods.
• QA Representative: Verifies proper implementation and documentation of monograph references and deviations.
• Method Development Lead: Reviews monograph adaptation rationale and approves any modifications required for practical use.
• Head – AMD: Ensures compliance and authorization of any validated in-house modifications.

4. Accountability

The Head of Analytical Method Development is accountable for ensuring that pharmacopoeial monographs are interpreted, applied, and documented correctly within the development and validation process.

5. Procedure

5.1 Access and Identification

1. Access the latest edition or supplement of official pharmacopoeias (IP, USP, BP, Ph.Eur, JP) via licensed digital or hardcopy sources.
2. Ensure access rights are valid and licenses are updated annually by the regulatory compliance officer.
3. Identify applicable monographs using either:
   • Generic drug substance or product name
   • CAS number or chemical name
   • INN/USAN (International or United States Adopted Name)

5.2 Review of Monograph Content

1. Review the following sections of each monograph:
   • Description
   • Identification Tests
   • Assay Procedure
   • Impurities
   • Other applicable tests (pH, LOD, Water Content, etc.)
2. Record the monograph version and year in Annexure-1: Monograph Review Log.

5.3 Comparison with Internal Methods

1. Compare the pharmacopoeial method with existing internal or validated methods for the same analyte or dosage form.
2. Document differences in parameters such as:
   • Column type
   • Mobile phase composition
   • Flow rate and gradient
   • Detection wavelength
   • Acceptance criteria
3. Log observations in Annexure-2: Comparative Evaluation Sheet.

5.4 Justification for Non-Compliance

1. If deviations from the monograph are necessary, provide a scientific rationale based on:
   • Product matrix
   • Specificity or sensitivity issues
   • Column incompatibility or availability
2. Document the justification in the Method Development Report and obtain QA review.

5.5 Incorporation into Method Development

1. Incorporate applicable pharmacopoeial elements into the new or revised method protocol.
2. If full adoption is feasible, proceed with method verification.
3. If modified, perform partial or full revalidation per internal validation SOP.

5.6 Documentation and Archival

1. Include a printed or PDF copy of the monograph in the method development file with version/date reference.
2. Index the monograph against the respective product name, method ID, and project code.
3. Ensure archival as per document control SOP for a minimum of 5 years or product lifecycle, whichever is longer.

6. Abbreviations

• IP: Indian Pharmacopoeia
• USP: United States Pharmacopeia
• BP: British Pharmacopoeia
• Ph.Eur: European Pharmacopoeia
• JP: Japanese Pharmacopoeia
• QA: Quality Assurance
• INN: International Nonproprietary Name
• SOP: Standard Operating Procedure

7. Documents

1. Monograph Review Log – Annexure-1
2. Comparative Evaluation Sheet – Annexure-2

8. References

• ICH Q6A – Specifications: Test Procedures and Acceptance Criteria
• Official Pharmacopoeias (USP, IP, BP, Ph.Eur, JP)
• WHO Technical Report Series No. 996

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Monograph Review Log

Monograph Name	Pharmacopoeia	Edition	Reviewed By	Date
Paracetamol Tablets	IP	2022	Rajesh Kumar	10/04/2025
Ciprofloxacin HCl	USP	43-NF38	Sunita Reddy	12/04/2025

Annexure-2: Comparative Evaluation Sheet

Parameter	Pharmacopoeial Method	In-House Method	Remarks
Column	C18, 250mm × 4.6mm, 5μm	C8, 150mm × 4.6mm, 3μm	Column switch due to pressure limits
Mobile Phase	Phosphate buffer:Acetonitrile (70:30)	Phosphate buffer:Methanol (60:40)	Methanol improves peak shape

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
04/05/2025	2.0	Updated monograph log format and annexures	Harmonization with regulatory audits