How to properly carry out an Analytical Method Transfer?

How to properly carry out an Analytical Method Transfer?

Analytical method transfer forms an important step of drug discovery and development as it stimulates the development of new drug product, clinical testing, or indicates the release of stability testing at a laboratory. The method transfer is achieved with the purpose of documenting the fact that a testing laboratory has the qualification of conducting already validated analytical methods for generating GMP-compliant data.

Types of Analytical Method Transfer Comparative Testing The comparative testing analysis is carried out by the two laboratories on the same API. The acceptance criteria after the analysis are matched. Both the acceptance variability and criteria are mentioned in the transfer protocol.

Co-Validation Testing The co-validation testing is achieved with an inter-laboratory verification process conducted by both the transferring and receiving laboratories. Using the transfer protocol, the assessment is concluded and reproducibility of the method is achieved.

Revalidation Partial validation of the analytical method is also considered in analytical method transfer.

Sometimes, this is necessary in the case of a method change.

In some cases, the laboratories can opt for transfer wavier, following which the need for analytical method transfer is eliminated. The method is transferred to the receiving laboratory without generating inter-lab data. However, this is only possible after the risk analysis of the laboratory’s experience, knowledge, and criticality of the method.

Key Points of Consideration for Analytical Method Transfer ● ● ● ● ● ● ●

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The receiving laboratory should evaluate the availability of the test material, equipment, and system of the method transfer beforehand.

The receiving laboratory should calibrate these systems or equipment prior to method transfer so that the specifications can be achieved and compliance can be maintained.

The transferring laboratory should ship standards, samples, methods, validation methods, and required documents to the receiving laboratory prior to the AMT. The transferring laboratory should train the receiving laboratory for handling the critical aspects whenever and wherever required.

Before starting the analytical method transfer, the receiving laboratory is required to conduct a test run for methods, procedures, and processes.

All the involved scientists and lab analysts should be properly trained to conduct the method transfer without any errors.

Only a single instance of the API should be tested. This is due to the fact that method transfer is not a manufacturing procedure. Hence, additional lots are tested only when required.

The protocol should be reviewed and approved by receiving and transferring laboratories. This should include acceptance criteria, performance parameters, required materials, and result evaluation.

The analytical method formed by the receiving laboratory should be unambiguous.

Pre-transfer assessments should be made to remediate underlying issues and errors.

Various impending issues can surface during the method transfer such as: ● ● ● ● ●

Inconsistent method instructions.

Poorly written use of the method.

Inconsistencies in relative response factors of impurity methods.

Arbitrary or ambiguous acceptance criteria.

Bias included in the outcome.

The final report which summarizes the results of the analytical method transfer should be correctly prepared. This report should contain results, variations, and glitches observed during experimentation. The report should conclude by confirming the transfer of the method to the receiving laboratory.

For more details click- ​Analytical Method Transfer