any external testing laboratory. It ensures consistency, reproducibility, and compliance with ICH, FDA, and WHO regulatory expectations.

2. Scope

This SOP applies to all dissolution test methods developed in AMD and intended to be transferred to a QC lab (internal or contract site) for routine product release, stability testing, or validation support.

3. Responsibilities

• Sending Lab (AMD): Prepares method transfer protocol, shares method details, provides standards, and supports training.
• Receiving Lab (QC/External): Performs trial runs, documents results, and submits method transfer report.
• QA Department: Ensures oversight of the process, reviews all documents, and approves outcomes.
• Head – AMD: Authorizes initiation and completion of the method transfer activity.

4. Accountability

The Head of Analytical Method Development is accountable for ensuring that all method transfers are executed as per SOP, with documented evidence of successful performance at the receiving unit.

5. Procedure

5.1 Initiation and Planning

1. Identify the dissolution method to be transferred and receiving location.
2. Confirm that the method is validated or has acceptable pre-validation data.
3. Draft a Method Transfer Protocol including:
   • Scope and objectives
   • Roles of sender and receiver
   • Acceptance criteria
   • Materials, standards, equipment
   • Timeline
4. Obtain QA approval before execution.
5. Document initiation in Annexure-1: Method Transfer Initiation Log.

5.2 Transfer of Method Details

1. Provide the receiving lab with:
   • Final validated method (SOP format)
   • Analytical method validation report
   • Standard operating conditions and rationale
   • Reference standards and sample batch
   • Stability of standard and sample solution
2. If equipment differences exist (e.g., different brand of dissolution tester), document rationale and adjust parameters only with scientific justification.
3. Log all shared documents and materials in Annexure-2: Transfer Document Checklist.

5.3 Trial Runs at Receiving Lab

1. Perform three sets of dissolution tests (n=6) using provided method and materials.
2. Analyze and calculate:
   • % drug release at all time points
   • % RSD per time point
   • f2 similarity with AMD profile (if applicable)
3. Ensure that results meet acceptance criteria:
   • % release variation ≤ 10%
   • % RSD ≤ 10% for all points
   • Profile matches reference profile with f2 ≥ 50
4. Record data in Annexure-3: Receiving Lab Trial Report.

5.4 Troubleshooting (if required)

1. If acceptance criteria are not met:
   • Conduct joint investigation by both labs
   • Evaluate system suitability, analyst error, instrument settings
   • Repeat runs under supervision if necessary
2. Document all findings in Annexure-4: Deviation and Resolution Record.

5.5 Completion and Approval

1. Compile a Method Transfer Report including:
   • Summary of trial results
   • Confirmation of acceptance criteria
   • Any deviations and corrective actions
2. QA to review and approve final report.
3. Update method status to “Transferred” in AMD records.
4. Close project with approval from Head – AMD and Head – QC.
5. Document in Annexure-5: Method Transfer Completion Log.

6. Abbreviations

• QC: Quality Control
• AMD: Analytical Method Development
• RSD: Relative Standard Deviation
• f2: Similarity Factor
• SOP: Standard Operating Procedure

7. Documents

1. Method Transfer Initiation Log – Annexure-1
2. Transfer Document Checklist – Annexure-2
3. Receiving Lab Trial Report – Annexure-3
4. Deviation and Resolution Record – Annexure-4
5. Method Transfer Completion Log – Annexure-5

8. References

• ICH Q2(R1) – Validation of Analytical Procedures
• WHO Technical Report Series – Transfer of Analytical Methods
• USP <1224> – Transfer of Analytical Procedures

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Method Transfer Initiation Log

Method ID	Product	Transfer To	Initiated By	Date
AMD-MT-105	Tablet A	QC Lab – Unit II	Rajesh Kumar	15/05/2025

Annexure-2: Transfer Document Checklist

Document/Item	Sent?	Remarks
Method SOP	Yes	Verified
Reference Standard	Yes	Batch RS-23/2025
Validation Report	Yes	Full validation included

Annexure-3: Receiving Lab Trial Report

Trial No.	% Released (30 min)	% RSD	Status
Trial 1	92.1%	3.2%	Pass
Trial 2	91.8%	2.9%	Pass
Trial 3	92.3%	3.5%	Pass

Annexure-4: Deviation and Resolution Record

No deviations reported during method transfer trials.

Annexure-5: Method Transfer Completion Log

Transfer Date	Receiving Analyst	Reviewed By	Final Approval
18/05/2025	Sunita Reddy	QA Officer	Head – AMD

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
04/05/2025	2.0	Added f2 similarity factor and annexures for trial reporting	Annual Review