SOP for Technology Transfer of Analytical Methods in AMD
| Department | Analytical Method Development |
|---|---|
| SOP No. | SOP/AMD/029/2025 |
| Supersedes | SOP/AMD/029/2022 |
| Page No. | Page 1 of 15 |
| Issue Date | 19/05/2025 |
| Effective Date | 20/05/2025 |
| Review Date | 19/05/2026 |
1. Purpose
This SOP describes the procedure for transferring analytical methods from the Analytical Method Development (AMD) department to receiving laboratories such as Quality Control (QC), contract research organizations (CROs), or manufacturing site labs. The goal is to ensure consistent method performance, data integrity, and compliance with regulatory expectations.
2. Scope
This SOP applies to all validated or qualified analytical methods that are intended for transfer from AMD to other internal or external laboratories for routine analysis, including assay, dissolution, impurity, residual solvents, identification, and other critical quality attribute (CQA) tests.
3. Responsibilities
- Sending Unit (AMD): Provides the validated method, method transfer protocol, training, and technical support.
- Receiving Unit (QC or CRO): Conducts method verification or comparative testing as per the transfer plan.
- QA: Oversees the integrity of the transfer process and ensures documentation is compliant with GMP and ICH guidelines.
- Head – AMD: Approves the technology transfer dossier and final report.
4. Accountability
The Head of AMD is accountable for ensuring complete and accurate transfer of analytical methods and successful verification at the receiving site.
5. Procedure
5.1 Initiation of Technology Transfer
- Trigger: Regulatory approval, site readiness, or commercial launch requirement.
- Initiate a method transfer request and assign a unique transfer ID (e.g., MTD/2025/001).
- Record details using Annexure-1: Method Transfer Initiation Form.
5.2 Transfer Package Preparation
- Prepare a transfer dossier including:
- Final validated method (version controlled)
- Method development report
- Validation report
- System suitability and troubleshooting guide
- Approved SOPs for critical steps
- Standard and placebo preparation procedures
- Representative chromatograms/spectra
- Include in Annexure-2: Method Transfer Dossier Checklist.
5.3 Transfer Protocol Design
- Prepare and approve a transfer protocol that includes:
- Scope and objective
- Test parameters and acceptance criteria
- Sample types and quantities
- Standard reference lot details
- Statistical comparison methods
- Document protocol in Annexure-3: Method Transfer Protocol Template.
5.4 Execution of Transfer Study
- Provide training to receiving unit analysts, as needed.
- Ensure environmental and equipment equivalency (column, instrument, software).
- Conduct parallel testing or comparative studies (typically 3 independent assays by each lab).
- Document results in Annexure-4: Method Transfer Execution Log.
5.5 Review and Approval
- Compile a transfer report that includes:
- Raw data comparison
- Statistical analysis (e.g., t-test, ANOVA)
- Any deviations and corrective actions
- QA and Head – AMD must review and approve the final report using Annexure-5: Method Transfer Completion Record.
- File the report in the AMD archive and share an electronic copy with the receiving unit.
5.6 Handling Discrepancies
- If the method fails transfer acceptance criteria:
- Initiate deviation report
- Perform root cause analysis
- Revise method parameters or conduct retraining
- Re-execute transfer protocol if required with QA oversight.
6. Abbreviations
- AMD: Analytical Method Development
- QC: Quality Control
- ICH: International Council for Harmonisation
- CRO: Contract Research Organization
- CQA: Critical Quality Attribute
7. Documents
- Method Transfer Initiation Form – Annexure-1
- Method Transfer Dossier Checklist – Annexure-2
- Method Transfer Protocol Template – Annexure-3
- Method Transfer Execution Log – Annexure-4
- Method Transfer Completion Record – Annexure-5
8. References
- ICH Q14 – Analytical Procedure Development
- WHO TRS 996 – Good Practices for Transfer of Technology
- ICH Q10 – Pharmaceutical Quality System
- USP General Chapter <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 Form
| Transfer ID | Product Name | Method Type | Receiving Lab | Date |
|---|---|---|---|---|
| MTD/2025/001 | Atorvastatin Tablets | Assay | QC Lab B | 01/05/2025 |
Annexure-2: Method Transfer Dossier Checklist
| Document | Included | Remarks |
|---|---|---|
| Validated Method | Yes | Signed copy attached |
| System Suitability Guidance | Yes | Included |
Annexure-3: Method Transfer Protocol Template
| Parameter | Acceptance Criteria | Test Type |
|---|---|---|
| Assay (%LC) | 98.0–102.0% | Comparative |
| RT Variability | ±2% | Instrumental |
Annexure-4: Method Transfer Execution Log
| Date | Lab | Analyst | Trial No. | Result |
|---|---|---|---|---|
| 05/05/2025 | QC Lab B | Ajay Mehra | 1 | 101.2% |
Annexure-5: Method Transfer Completion Record
| Transfer ID | Approved By | Approval Date | Comments |
|---|---|---|---|
| MTD/2025/001 | Dr. Vinay Pawar | 15/05/2025 | Method successfully transferred |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 04/05/2025 | 2.0 | Updated to include statistical analysis and deviation handling steps | Regulatory recommendation |