testing of materials used and produced in API manufacturing. It covers comparative testing, documentation, training, and approval steps required prior to implementation in QC.

3. Responsibilities

• Method Development Scientist: Provide all validated method details, protocols, and demonstration data.
• QC Analyst: Perform comparative testing and data recording as per transfer protocol.
• QC Reviewer: Verify compliance of results and review of transfer reports.
• QA Officer: Approve method readiness and control implementation in routine use.

4. Accountability

The QC Head is accountable for ensuring that analytical methods are transferred, verified, and adopted into routine QC operations as per GMP and regulatory requirements.

5. Procedure

5.1 Initiation of Method Transfer

1. The R&D/ADL team shall submit the following to the QC department:
   • Validated method protocol
   • Validation summary report
   • Reference standards and working solutions (if applicable)
   • Training presentation or demonstration session
2. The QC Head, in coordination with QA, initiates a Method Transfer Protocol (Annexure-1) outlining:
   • Test parameters
   • Acceptance criteria
   • Number of analysts
   • Number of runs and sample types

5.2 Comparative Testing in QC

1. QC performs side-by-side or replicate testing of 3–5 sample sets using:
   • The method provided
   • Standard test materials with known values
2. Record:
   • Accuracy, precision (repeatability, intermediate precision)
   • Specificity, linearity (if applicable)
   • System suitability
3. All observations must be documented in the Method Transfer Log (Annexure-2).

5.3 Evaluation and Reporting

1. Compare observed data to validation results and acceptance limits.
2. If results meet acceptance criteria:
   • Prepare Method Transfer Report (Annexure-3)
   • Obtain QA review and approval
3. If not acceptable:
   • Investigate root cause (analyst error, equipment variability, material quality)
   • Repeat transfer only after corrective action

5.4 Training and Implementation

1. Train all QC personnel on the transferred method using a Method Training Record (Annexure-4).
2. Ensure reference standards, reagents, and equipment for the method are available and qualified.
3. Update the STP index, method directory, and QC master schedule.

5.5 Final Approval and Routine Usage

1. Upon successful transfer, QA issues a formal approval memo for method implementation.
2. The method becomes part of routine QC testing activities.
3. Retain all related documents in the Method Transfer Dossier for audit readiness.

6. Abbreviations

• QC: Quality Control
• QA: Quality Assurance
• ADL: Analytical Development Laboratory
• STP: Standard Test Procedure
• SOP: Standard Operating Procedure

7. Documents

1. Method Transfer Protocol (Annexure-1)
2. Method Transfer Log (Annexure-2)
3. Method Transfer Report (Annexure-3)
4. Method Training Record (Annexure-4)

8. References

• ICH Q2(R1) – Validation of Analytical Procedures
• 21 CFR Part 211
• ICH Q10 – Pharmaceutical Quality System

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 Protocol

Method Name	Assay of API X
Validated By	ADL
Transfer Site	QC Lab
No. of Analysts	2
Samples	3 batches

Annexure-2: Method Transfer Log

Date	Analyst	Sample ID	Test	Result	Comments
13/04/2025	Sunita Reddy	API-B001	Assay	99.5%	Within limits

Annexure-3: Method Transfer Report

Method Name	Assay of API X
Transfer Outcome	Successful
Deviation Noted	No
QA Review	Approved

Annexure-4: Method Training Record

Analyst Name	Method Name	Trainer	Training Date	Remarks
Ravi Kumar	Assay of API X	QC Supervisor	13/04/2025	Trained

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Version	Regulatory Requirement	QA Head
13/04/2025	2.0	Inclusion of Training Record and QA Memo	Internal Audit Suggestion	QA Head