methods between laboratories.

2. Scope

This SOP applies to the Analytical Method Development department and all Quality Control laboratories involved in the transfer of analytical methods for drug substances and drug products, either within the organization or to a contract testing laboratory (CTL).

3. Responsibilities

• Sending Unit (SU) Scientist: Drafts the AMT protocol, provides method training and standard documentation.
• Receiving Unit (RU) Analyst: Executes the transfer protocol as per instructions.
• QA Team: Reviews and approves the protocol and ensures compliance with regulatory guidelines.

4. Accountability

The Head of Analytical Method Development is accountable for ensuring the preparation, review, and approval of transfer protocols are consistent with ICH and regulatory requirements.

5. Procedure

5.1 Components of the Transfer Protocol

1. Title Page: Includes method name, product, batch number, SU and RU, document number, version, and approval section.
2. Objective: Define the goal and scope of the transfer.
3. Method Summary: Brief method description, equipment, reagents, columns, and acceptance criteria.
4. Test Parameters: Include at least:
   • Assay
   • Impurity profile
   • pH, dissolution, identification (as applicable)
5. Number of Batches: Specify sample matrix and quantity (e.g., 3 lots or 1 lot x 3 replicates).
6. System Suitability Criteria: As per the validated method (e.g., %RSD, resolution).
7. Acceptance Criteria: Define criteria for equivalency based on % difference, %RSD, mean comparison.
8. Deviation Handling: Include steps for documenting and investigating deviations.
9. Reporting Requirements: Define format, timelines, and responsible parties.

5.2 Format and Documentation

• Protocol shall follow internal documentation numbering format.
• Attach validated method SOP, standard operating worksheets, and method validation summary report as appendices.
• Each section should have traceable signatures and version control.

5.3 Regulatory Reference and Best Practices

• Protocols should align with ICH Q2(R1), WHO TRS 961 Annex 7, and FDA guidance on method transfers.

6. Abbreviations

• AMT: Analytical Method Transfer
• SU: Sending Unit
• RU: Receiving Unit
• CTL: Contract Testing Laboratory
• RSD: Relative Standard Deviation

7. Documents

1. Analytical Method Transfer Protocol Template – Annexure-1
2. Sample Tracking Log – Annexure-2
3. System Suitability Record – Annexure-3

8. References

• ICH Q2(R1): Validation of Analytical Procedures
• WHO TRS 961, Annex 7: Transfer of Technology
• 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	Manasi Kulkarni	Vikram Chopra	Sunita Reddy
Designation	Analytical Method Scientist	QA Reviewer	Head – AMD
Department	Analytical Method Development	QA	Analytical Method Development

11. Annexures

Annexure-1: Analytical Method Transfer Protocol Template

Protocol ID	AMT/2025/006
Method	Assay and Related Substances by HPLC
Product	Paracetamol Tablets 500 mg
SU	PharmaDev Labs, Hyderabad
RU	PharmaQC Unit, Pune

Annexure-2: Sample Tracking Log

Sample ID	Batch No.	Qty (g)	Date Sent	Received By
TRF-AMT-01	PT500B2301	20 g	10/05/2025	Anita Desai

Annexure-3: System Suitability Record

Test	Criteria	Result	Status
%RSD (n=6)	NMT 2.0%	1.4%	Pass
Resolution (API vs Impurity A)	NLT 2.0	2.5	Pass

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
21/05/2025	2.0	Revised to include WHO Annex 7 references and deviation handling process	Annual Review	Sunita Reddy
10/10/2022	1.0	Initial SOP Release	New SOP	QA Head