FDA guidance on method transfer is a kind of conundrum. On the one hand, there should be no complexity in analytical method transfer because the nature of method transfer is simple. On the other hand; there are no clearly defined guidelines on the subject from the FDA, making it something of a system that is free wheel in grand self-contradictory. The fact that the FDA is not the only regulatory body that has guidelines on method transfer adds to the lack of a straight jacketed approach to the topic.
So, what is FDA guidance on method transfer?
Although there are no specified and clearly laid out guidance from the FDA on method transfer; these guidelines cover some forms of method transfer. They are based on the fact that analytical method transfer is the manner by which a laboratory becomes qualified to use a test procedure.
The pivot on which FDA guidance on method transfer revolves is that it is incumbent upon transferring and receiving laboratories to be compliant with set guidelines when they transfer or receive analytical methods. These guidelines in turn are governed by statistical and practical treatment of the resulting data.
Does the FDA have guidance on re validation?
Yes. FDA guidance on method transfer covers re-validation. Any receiving or transferring laboratory has to carry out re-validation of the method transfer in these circumstances:
- When a method gets changed, and the new parameter is beyond the operating range
- When there is a change or extension in the scope of the method
- If a change of sample matrix/operating conditions contributed to the change of the scope of the method
- If new instruments, meaning those whose characteristics were not covered by the initial validation are used in the validation
- Where system suitability tests, or results of sample analysis, depart from preset acceptance criteria and when the source of this error cannot be traced to be fixed later
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