the method performs reliably under routine laboratory conditions and complies with GMP and ICH Q14/Q2(R2) guidelines.

2. Scope

This SOP is applicable to all validated analytical methods developed for drug substances, drug products, raw materials, and intermediates that are to be implemented in the Quality Control laboratory.

3. Responsibilities

• AMD Analyst: Prepares and shares method transfer documentation and reference standards.
• QC Analyst: Executes transfer verification runs and records observations.
• AMD/QC Group Leaders: Coordinate and supervise the transfer activity.
• QA Executive: Reviews transfer protocol and report; approves final documentation.

4. Accountability

The Heads of Analytical Method Development and Quality Control are jointly accountable for the successful execution and documentation of method transfer activities.

5. Procedure

5.1 Pre-Transfer Review

1. Confirm that the method is fully validated as per ICH Q2(R1) or Q14 requirements.
2. Ensure the following documents are ready:
   • Method of analysis (MoA)
   • Validation report
   • Standard operating procedures
   • Reference standards and sample materials

5.2 Method Transfer Planning

1. Prepare a Method Transfer Protocol including:
   • Transfer approach: Comparative testing or co-validation
   • Number of replicates, acceptance criteria, instruments to be used
   • List of materials, batch numbers, analysts, timelines
2. Get the protocol reviewed by QA and approved prior to execution.

5.3 Execution of Transfer

1. Conduct testing in AMD and QC labs in parallel or sequentially.
2. Perform at least 6 replicate sample and standard analyses at both sites.
3. Compare the following parameters:
   • % Assay values
   • % RSD of replicate injections
   • System suitability criteria (RT, Rs, N, T)
4. Document all observations in Annexure-1 and Annexure-2.

5.4 Data Evaluation

1. Evaluate transfer success based on:
   • Difference in assay between labs ≤ 2.0%
   • System suitability passed
   • Acceptance criteria met for all key parameters
2. Summarize results in Annexure-3: Method Transfer Summary Report.

5.5 Post-Transfer Steps

1. QA to review and approve the report.
2. Update SOPs in QC lab with the transferred method.
3. Train QC analysts and file training records.

6. Abbreviations

• SOP: Standard Operating Procedure
• QC: Quality Control
• AMD: Analytical Method Development
• QA: Quality Assurance
• MoA: Method of Analysis

7. Documents

1. Inter-Laboratory Data Sheet – Annexure-1
2. System Suitability Log – Annexure-2
3. Method Transfer Summary Report – Annexure-3

8. References

• ICH Q14: Analytical Procedure Development
• ICH Q2(R2): Analytical Procedure Validation
• GMP Guidelines – Schedule M (India)

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Meenal Deshmukh	Vikas Trivedi	Sunita Reddy
Designation	Method Transfer Chemist	QA Reviewer	Department Head
Department	AMD	QA	Analytical Method Development

11. Annexures

Annexure-1: Inter-Laboratory Data Sheet

Parameter	AMD Lab	QC Lab	Difference	Status
% Assay	98.9%	99.2%	0.3%	Pass
% RSD	0.7%	0.6%	–	Pass

Annexure-2: System Suitability Log

Lab	RT	Resolution	Theoretical Plates	Status
AMD	5.2	2.5	3200	Pass
QC	5.1	2.4	3100	Pass

Annexure-3: Method Transfer Summary Report

Method Title	Assay of Levofloxacin
Transfer Date	18/05/2025
Transfer Type	Comparative Testing
Transfer Status	Successful
Remarks	All parameters within acceptable range

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
21/05/2025	2.0	Aligned with ICH Q14	Annual Update	Sunita Reddy
10/02/2022	1.0	Initial Release	New SOP	QA Head