Analytical method development and validation are among the most critical parts of the drug discovery and development. Majorly, all those products which are clinically successful, analytical method transfer becomes a necessity. This is a crucial process developed for verifying that a given analytical laboratory is capable of performing analytical method transfers aimed at resolving their intended use.
While performing analytical method transfer, it becomes a necessity to base the analytical method transfer approach under the drug development stage at which it is being applied. The analytical method transfer strategy should be affixed following the nature of the analyte, its validation status, intended pharmaceutical product, and the overall analytical experience of the laboratories involved in the transfer.
Method type, experimental design, and data analysis should be defined according to each stage of analysis. This is done to comply with regulatory expectations.
Essential elements of analytical method transfer
Comparative testing is a generalized analytical method transfer procedure where both the laboratories are involved. Here, the same sample is subjected to analytical testing at both the originating and receiving laboratory. The results obtained at both places are then compared with each other. The entire comparative testing is accomplished by a pre-approved testing protocol defined by pre-approved testing parameters. Occasionally, a comparative testing approach can be clubbed with other post-approval analytical testing parameters, which involves other contract laboratories and additional manufacturing sites. Usually, comparative testing is reserved for later stages of complex analytical method transfers.
The co-validation process is an alternative to the traditional comparative mode of testing. Here, the receiving analytical laboratory is involved in the method transfer right from the validation protocol. As soon as the method transfer process is accomplished, the principal analyst involved in the whole scenario qualifies the analytical method for the final release testing. This validation process requires the receiving laboratory to identify the intermediate precision validation parameters for evaluation in conjunction with the experimental design.
Waivers for analytical method transfer
In analytical testing, you may come across certain instances where the formal analytical method may not be applicable or essentially required. These include –
- If the receiving laboratory is always involved in product testing and is quite familiar with the analytical method being employed in the testing
- When the receiving laboratory is already familiar with the method or procedure for testing a comparable dosage form of the drug candidate intended to be tested.
- If the analytical method is already available in the market and is being widely used
- When an existing analytical testing method has been wholly or slightly modified; however, no effect is produced on its validation status.
Final Execution of the Analytical Method Transfer
Before executing the final analytical method transfer, the clinical team needs to evaluate the feasibility of the work undertaken and ensure that all the paperwork has been accomplished. Any gap analysis, if present, should be thoroughly worked out; a solid foundation for the analytical method transfer should be established, and the testing window of both the laboratories should be controlled and well-regulated.
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