Analytical Method Transfer (AMT) is the systematic process of transferring validated analytical test methods from the sending lab to the receiving lab to ensure consistent product quality testing.
Key Aspects of Analytical Method Transfer (AMT) in TT:
Purpose: Ensures the receiving lab can perform tests with the same accuracy, precision, and consistency as the sending lab.
Protocol Development: An AMT protocol outlines the scope, objectives, acceptance criteria, and steps for the transfer.
Method Familiarization: Training sessions introduce the receiving lab to the method’s procedures and requirements.
Transfer Testing: The receiving lab conducts tests with specified samples, and results are compared with those from the sending lab.
Comparison & Evaluation: Results are compared against acceptance criteria, and discrepancies are investigated.
Documentation: All activities, results, and observations are recorded to maintain a clear transfer history.
Final Approval: Upon meeting acceptance criteria, the transfer concludes with formal approval and documentation.
Steps Involved:
Method Assessment: Reviewing method suitability for transfer.
Transfer Strategy:
Comparative Testing: Testing samples at both SU and RU.
Co-Validation: Joint validation efforts.
Documentation: Preparing detailed method transfer protocols and reports.
Analytical Method Transfer (AMT) refers to the process of formally and systematically transferring validated analytical test methods from one laboratory (often the sending or originating site) to another (the receiving site).
Challenges and Troubleshooting:
Equipment Differences: Variations in instruments can affect results.
Staff Training: Ensuring personnel are proficient in methods.
Environmental Factors: Differences in lab conditions.