This includes data compilation, result evaluation, interpretation of acceptance criteria, deviation handling, and documentation to ensure regulatory compliance and traceability.

2. Scope

This SOP is applicable to all analytical method transfers—qualitative and quantitative—conducted between the Sending Unit (SU) and Receiving Unit (RU) within the organization or with external contract laboratories.

3. Responsibilities

• RU Analyst: Submits all raw data, observations, and completed worksheets to AMD representative.
• SU Scientist: Assists in data interpretation and comparative analysis between SU and RU performance.
• QA Reviewer: Reviews report content, verifies completeness, and ensures compliance with method transfer protocol.
• AMD Documentation Officer: Compiles the transfer report in standardized format and files it with supporting annexures.

4. Accountability

The AMD Section Head is accountable for ensuring the preparation, review, approval, and archival of all analytical method transfer reports and associated summaries as per GMP requirements and ICH guidelines.

5. Procedure

5.1 Collection and Verification of Data

1. Collect raw data from RU including instrument printouts, chromatograms, method execution worksheets, and calibration records.
2. Cross-check against SU method parameters for alignment with transfer protocol.
3. Ensure inclusion of data from system suitability, precision, accuracy, linearity, robustness, and ruggedness evaluations.

5.2 Data Compilation and Tabulation

1. Use Annexure-1 format to compile test parameters, results from SU and RU, and acceptance criteria.
2. Document variations and highlight critical deviations observed during execution.
3. Summarize key statistical metrics (e.g., RSD, % Recovery, correlation coefficients) for each validation attribute.

5.3 Transfer Summary Drafting

1. Write a summary of the transfer exercise, including:
• Purpose and scope of transfer
• Test parameters and methodology
• Comparison of SU and RU results
• Outcome of acceptance criteria evaluation
• Summary of deviations and resolutions
2. Attach graphical representation where applicable (e.g., overlaid chromatograms, linearity curves).

5.4 Deviation Management and CAPA

1. For any deviations noted, record in Deviation Log (Annexure-2).
2. Perform Root Cause Analysis (RCA) using Ishikawa diagram or 5-Whys analysis.
3. Document CAPA plan, timelines, and responsible personnel in the report summary.

5.5 Approval and Archival

1. Submit completed Transfer Report and Summary to QA for review and approval.
2. Ensure all supporting documentation including instrument logs, audit trails, and batch records are included.
3. Assign report ID and archive the approved version in the central AMD documentation repository.

6. Abbreviations

• RU: Receiving Unit
• SU: Sending Unit
• RSD: Relative Standard Deviation
• CAPA: Corrective and Preventive Action
• RCA: Root Cause Analysis

7. Documents

1. Method Transfer Report Template – Annexure-1
2. Deviation Log Format – Annexure-2
3. CAPA Summary Sheet – Annexure-3

8. References

• ICH Q2(R1) – Validation of Analytical Procedures
• ICH Q9 – Quality Risk Management
• WHO Technical Report Series 996, Annex 7
• 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	Sachin Kumar	Priya Nair	Dr. Harshita Goyal
Designation	AMD Analyst	QA Reviewer	Head – Analytical Method Development
Department	Analytical Method Development	Quality Assurance	Analytical Method Development

11. Annexures

Annexure-1: Method Transfer Report Template

This includes: protocol ID, RU and SU names, method description, acceptance criteria, detailed comparative result table, summary of observations, and conclusions.

Annexure-2: Deviation Log Format

Deviation ID	Description	Root Cause	Corrective Action	Status
DEV-304-01	High RSD in robustness test	Improper sample dilution	Training and dilution SOP revision	Closed

Annexure-3: CAPA Summary Sheet

Details CAPA issued for deviation: assigned actions, deadlines, responsible analysts, and effectiveness check strategy.

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2025	2.0	Enhanced structure and clarified statistical reporting guidance	Annual SOP review	Dr. Harshita Goyal
15/07/2022	1.0	Initial Release	New SOP	QA Head