subjected to significant changes. The goal is to ensure that the method is suitable under actual conditions of use in the receiving laboratory and complies with applicable regulatory guidelines such as ICH Q2(R1), WHO, and FDA requirements.

2. Scope

This SOP applies to all analysts, supervisors, and quality reviewers involved in the analytical method verification (AMV) activities in the Analytical Method Development (AMD) department. It covers methods for active pharmaceutical ingredients (APIs), excipients, raw materials, in-process samples, and finished pharmaceutical products.

3. Responsibilities

• Analyst: Performs method verification experiments and records data as per protocol.
• Section Head: Reviews raw data and final results; initiates CAPA if necessary.
• QA Representative: Ensures protocol approval, compliance with SOPs, and archiving.

4. Accountability

The Head of Analytical Method Development is accountable for reviewing and approving all verification reports, and for ensuring proper documentation, traceability, and data integrity.

5. Procedure

5.1 Prerequisites for Verification

1. Ensure receipt of the original validated method along with method transfer protocol or justification for method adaptation.
2. Review previous validation data to identify critical parameters and known variability.
3. Ensure instruments used are qualified and calibrated.

5.2 Planning and Documentation

1. Develop a verification protocol outlining:
   • Scope and objectives
   • Test parameters and acceptance criteria
   • Materials and equipment used
   • Data evaluation strategy
2. Submit protocol to QA for review and approval before execution.

5.3 Verification Parameters

Verification must address critical attributes, typically including but not limited to:

• System Suitability: Plate count, tailing factor, resolution
• Precision: Repeatability (n=6), %RSD ≤ 2%
• Accuracy: % Recovery at 3 concentration levels (80%, 100%, 120%)
• Specificity: Blank, placebo, and matrix interference
• Linearity: 5 levels minimum, R² ≥ 0.998

5.4 Execution

1. Perform verification as per approved protocol under similar conditions of intended use.
2. Conduct triplicate runs where required for accuracy and precision parameters.
3. Record chromatograms, spectra, calculations, and observations clearly.

5.5 Data Evaluation

1. Evaluate data against predefined acceptance criteria.
2. If results fall outside the criteria, perform deviation investigation and RCA.
3. Summarize findings in the Verification Report (Annexure-2).

5.6 Approval and Archival

1. Submit final report for QA review and sign-off.
2. Ensure report includes all raw data, calculations, instrument logs, and analyst sign-offs.
3. Store approved report in AMD Document Control Archive.

6. Abbreviations

• AMV: Analytical Method Verification
• QA: Quality Assurance
• RSD: Relative Standard Deviation
• RCA: Root Cause Analysis
• CAPA: Corrective and Preventive Action

7. Documents

1. Annexure-1: Verification Protocol Template
2. Annexure-2: Verification Report Template
3. Annexure-3: Deviation & CAPA Log

8. References

• ICH Q2(R1): Validation of Analytical Procedures
• ICH Q9: Quality Risk Management
• WHO Technical Report Series, Annexes on Method Validation
• FDA Guidance for Industry – Analytical Procedures and Methods Validation

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Kajal Joshi	Manish Patel	Dr. Radhika Verma
Designation	Analyst – AMD	QA Manager	Head – Analytical Method Development
Department	Analytical Method Development	Quality Assurance	Analytical Method Development

11. Annexures

Annexure-1: Verification Protocol Template

Contains test parameters, materials, method reference, and acceptance criteria required for verification.

Annexure-2: Verification Report Template

Includes observed results, pass/fail evaluation, chromatograms, analyst signature, and summary.

Annexure-3: Deviation & CAPA Log

Deviation ID	Description	Root Cause	CAPA	Status
DEV-375-01	RSD above limit for precision	Improper mixing of standard	Retraining and SOP amendment	Closed

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2025	2.0	Updated verification parameters and reporting structure	Annual SOP Review	Dr. Radhika Verma
05/07/2022	1.0	Initial Issue	New SOP	QA Head