laboratories.

2. Scope

This SOP applies to all method transfer studies conducted between internal QC labs or external contract testing laboratories for drug substances, drug products, and related materials.

3. Responsibilities

• SU Scientist: Coordinates with RU, sends samples, reference standards, and method documents.
• RU Analyst: Executes the AMT as per protocol and records all observations.
• QA Representative: Reviews compliance and approves results as per protocol acceptance criteria.

4. Accountability

The Head of Analytical Method Development is accountable for ensuring method transfer studies are performed, evaluated, and reported according to regulatory guidelines and approved protocols.

5. Procedure

5.1 Pre-Execution Requirements

1. Ensure approval of the Method Transfer Protocol (refer SOP/AMD/296/2025).
2. Ensure both labs are qualified and analysts are trained in the method.
3. Verify calibration status of instruments and availability of all reagents.

5.2 Sample and Standard Handling

1. Receive sample and standard materials from SU along with CoAs.
2. Store materials under recommended conditions until analysis.
3. Log samples in the Sample Receipt Log (Annexure-1).

5.3 System Suitability and Method Execution

1. Conduct system suitability tests prior to each run.
2. Perform analysis in triplicate or as per protocol (e.g., 3 batches × 3 replicates).
3. Record chromatograms, calibration curves, raw data, and observations.

5.4 Data Evaluation

1. Compare RU results with SU historical or concurrent data.
2. Assess results based on acceptance criteria outlined in the protocol:
   • Assay: % difference NMT ±2.0%
   • Impurities: NMT 20% difference per impurity
   • RSD: NMT 2.0% (system and method precision)
3. Use statistical tools (e.g., Student’s t-test, f₂ for dissolution) if needed.

5.5 Handling Deviations

1. Document all deviations from the protocol.
2. Investigate root cause and propose corrective actions.
3. Record deviation summary in Annexure-2.

5.6 Completion and Reporting

1. Summarize findings in the Method Transfer Report (Annexure-3).
2. Attach all raw data, chromatograms, and summary tables.
3. Route the report for QA and final approval.

6. Abbreviations

• AMT: Analytical Method Transfer
• SU: Sending Unit
• RU: Receiving Unit
• QA: Quality Assurance
• RSD: Relative Standard Deviation

7. Documents

1. Sample Receipt Log – Annexure-1
2. Deviation Log – Annexure-2
3. Method Transfer Summary Report – Annexure-3

8. References

• ICH Q2(R1): Validation of Analytical Procedures
• WHO TRS 961, Annex 7
• FDA Guidance on Analytical Procedure Transfers

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Rajat Sinha	Meera Chavan	Sunita Reddy
Designation	Transfer Coordinator	QA Reviewer	Head – AMD
Department	Analytical Method Development	QA	Analytical Method Development

11. Annexures

Annexure-1: Sample Receipt Log

Sample ID	Material	Batch No.	Qty	Received Date	Storage
AMT297-01	API – Ibuprofen	IBU00123	25 g	15/05/2025	Room Temp

Annexure-2: Deviation Log

Deviation ID	Description	Root Cause	Corrective Action	Status
DEV/297/001	Unexpected peak in blank	Contamination	Used fresh diluent	Closed

Annexure-3: Method Transfer Summary Report

Method transfer completed for assay and impurity testing of Ibuprofen Tablets. Results met predefined criteria. RSD values ≤1.8%. No OOS or significant deviations observed.

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
21/05/2025	2.0	Expanded execution steps and statistical interpretation section	Annual SOP Review	Sunita Reddy
05/11/2022	1.0	Initial SOP Release	New SOP	QA Head