with regulatory expectations and internal quality standards.

2. Scope

This SOP applies to all method transfers conducted by the Analytical Method Development (AMD) department involving drug substances, drug products, excipients, and intermediates within internal laboratories or third-party contract testing laboratories (CTLs).

3. Responsibilities

• SU Scientist: Compiles the complete set of transfer-related documents and submits to QA.
• RU Representative: Reviews documentation and ensures laboratory readiness for method execution.
• QA Department: Reviews and approves the method transfer documentation, issues formal approval, and ensures traceability and archival.

4. Accountability

The Head of Analytical Method Development is accountable for ensuring that complete and accurate documentation is prepared and reviewed prior to initiating analytical method transfer studies.

5. Procedure

5.1 Documentation Package for Method Transfer Approval

1. Cover Letter: Request for approval including rationale and scope.
2. Validated Analytical Method SOP: Final version with revision history and effective date.
3. Analytical Method Validation Report: Summarizing system suitability, accuracy, precision, linearity, robustness, specificity, and LOQ/LOD.
4. Method Transfer Protocol: Drafted and approved (refer SOP/AMD/296/2025).
5. Training Documentation: Training records and certification of receiving analysts (Annexure-1).
6. Analytical Instrument Qualification: Certificate for the relevant equipment (HPLC, GC, UV, etc.).
7. Reference Standard and Reagents CoA: Current CoAs for all materials used in method execution.
8. Change Control Record: Number and status linked to the transfer event.

5.2 Format and Approval Process

1. Compile all documents in a predefined dossier format (Annexure-2).
2. Submit dossier to QA with method transfer approval request form (Annexure-3).
3. QA reviews, verifies content completeness, and signs off with approval status (Approved/Conditional/Rejected).

5.3 Distribution and Archival

1. Upon approval, provide soft and hard copies to RU and retain master set in QA archive.
2. Enter approval details in Method Transfer Approval Register (Annexure-4).
3. Assign a unique Method Transfer Approval Number (MTAN) to every transfer event.

6. Abbreviations

• AMD: Analytical Method Development
• SOP: Standard Operating Procedure
• SU: Sending Unit
• RU: Receiving Unit
• QA: Quality Assurance
• CoA: Certificate of Analysis

7. Documents

1. Analyst Training Record – Annexure-1
2. Method Transfer Dossier Format – Annexure-2
3. Approval Request Form – Annexure-3
4. Method Transfer Approval Register – Annexure-4

8. References

• ICH Q10: Pharmaceutical Quality System
• ICH Q2(R1): Validation of Analytical Procedures
• FDA Guidance on Analytical Procedure Transfer (2021)

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Ankita Mehra	Dr. Rajeev Sharma	Sunita Reddy
Designation	Method Transfer Coordinator	QA Reviewer	Head – AMD
Department	Analytical Method Development	QA	Analytical Method Development

11. Annexures

Annexure-1: Analyst Training Record

Analyst Name	Training Topic	Trainer	Date	Signature
Vikas Nanda	HPLC Assay Method	Neha Shastri	10/05/2025	Signed

Annexure-2: Method Transfer Dossier Format

Sections include: Cover Letter, Method SOP, Validation Report, Protocol, CoAs, Equipment Qualification, Training Certificates, and Change Control Record.

Annexure-3: Approval Request Form

Request ID	MTREQ-301-2025
Date	20/05/2025
Method	Assay of Azithromycin by HPLC
Requestor	Ankita Mehra
RU Site	QC Facility – Goa
Status	Approved

Annexure-4: Method Transfer Approval Register

MTAN	Method	RU	Date Approved	Approved By
MTAN/301/2025	Azithromycin Assay	Goa QC	21/05/2025	Sunita Reddy

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
21/05/2025	2.0	Revised to include approval register and dossier checklist	Annual SOP Review	Sunita Reddy
01/09/2022	1.0	Initial SOP Release	New SOP	QA Head