products.

2. Scope

This procedure applies to all pharmacopoeial methods (USP, BP, EP, IP, JP, etc.) adopted by the Analytical Method Development department prior to use in analysis without complete revalidation.

3. Responsibilities

• Analytical Scientist: Executes method verification protocol, documents and evaluates results.
• QA Reviewer: Reviews verification data and authorizes method approval.
• Documentation Officer: Maintains records of verified compendial methods and their associated documentation.

4. Accountability

The Head of Analytical Method Development is accountable for ensuring that compendial methods undergo proper verification to establish fitness for intended use and are compliant with regulatory standards.

5. Procedure

5.1 Review of Compendial Method

1. Obtain the latest version of the compendial method from official sources.
2. Review method parameters: sample preparation, detection wavelength, injection volume, flow rate, system suitability criteria.
3. Check for method applicability with specific formulation or matrix in question.

5.2 Preparation of Verification Protocol

1. Draft a protocol specifying:
   • Method description
   • Objective and scope of verification
   • Acceptance criteria
   • Verification parameters (e.g., specificity, precision, accuracy)
2. Get protocol reviewed and approved by QA.

5.3 Execution of Verification

1. Perform testing on relevant matrices using pharmacopoeial method under actual laboratory conditions.
2. Evaluate key parameters:
   • Specificity: No interference from excipients.
   • Precision: RSD within ±2% for assay or content uniformity.
   • Accuracy: Recovery within 98%–102% at 80%, 100%, and 120% levels.
   • System Suitability: Meets compendial criteria (e.g., resolution, tailing factor, theoretical plates).
3. Document observations and results in Annexure-1 format.

5.4 Evaluation and Reporting

1. Summarize results against protocol criteria in a Method Verification Report (Annexure-2).
2. Highlight any modifications or deviations from compendial method.
3. Submit report to QA for review and approval.

5.5 Method Approval and Release

1. After successful verification, tag method as “Verified for Use” and archive all documentation.
2. Enter method details into Analytical Method Master Index (Annexure-3).
3. Ensure only approved verified versions are used for testing.

6. Abbreviations

• RSD: Relative Standard Deviation
• QA: Quality Assurance
• USP: United States Pharmacopeia
• EP: European Pharmacopeia
• JP: Japanese Pharmacopoeia

7. Documents

1. Annexure-1: Compendial Method Verification Raw Data Sheet
2. Annexure-2: Method Verification Report Template
3. Annexure-3: Analytical Method Master Index

8. References

• ICH Q2(R1) – Validation of Analytical Procedures
• USP General Chapter <1226> – Verification of Compendial Procedures
• 21 CFR Part 211 – Good Manufacturing Practice for Finished Pharmaceuticals

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Arjun Patel	Meera Bansal	Dr. Rakesh Shetty
Designation	Analytical Chemist	QA Reviewer	Head – AMD
Department	Analytical Method Development	Quality Assurance	Analytical Method Development

11. Annexures

Annexure-1: Compendial Method Verification Raw Data Sheet

Document includes experimental conditions, raw results, analyst observations, system suitability results, recovery tables, and chromatograms if applicable.

Annexure-2: Method Verification Report Template

Includes method description, summary of findings, deviations (if any), conclusion, and QA approval.

Annexure-3: Analytical Method Master Index

Method ID	Method Title	Source	Verification Status	Date Verified
AMD-COMP-007	Assay of Ibuprofen Tablets	USP	Verified	27/05/2025

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2025	2.0	Added evaluation for excipient interference under specificity	Annual Review	Dr. Rakesh Shetty
15/07/2022	1.0	Initial version	New SOP	QA Head