Analytical method transfer

Analytical method transfer is an important element of a laboratory. A laboratory will be required to send or transfer its methods for a variety of reasons to another laboratory. During this process, analytical method transfer comes into play. Analytical method transfer has been described as“…the process of transferring a validated analytical method from a sending laboratory to a receiving laboratory, after demonstrating experimentally that it also masters the method”.

It follows from this definition that the analytical method transfer has to demonstrate at least three important components:

  • A study that is protocol-driven and has predetermined criteria for acceptance
  • Laboratories’ expertise in using and running a particular method has to be demonstrated
  • The method’s ability to fulfill its intended use must be verified.

Factors for the rise in use of transfer methods

Of late, there has been a discernible increase in the use of analytical method transfer. Some of the reasons for this phenomenon are an increase in outsourcing and subcontracting, which use methods like contract manufacturing and CRO’s. Added to this; there has been a general increase in the importance of bio pharmaceutical and biologic products of late, necessitating an increase in analytical method transfer. Because of this, the emphasis on good business practice and regulatory guidance has got reinforced.

How are analytical method transfer and validation related?

Analytical method transfer is closely intertwined with validation, for the simple reason that it is validated data that is transferred between laboratories. Unless data is verified; analytical method transfer is incomplete and unfruitful.

Difficulties involved in methods transfer between multiple laboratories

Challenges can arise when more than one company have to transfer data between multiple laboratories. This involves and requires having to use different approaches to transfer and validation. Also, the transfer is challenging and can become subjective, since the various laboratories involved in the transfer will have their own definitions and expectations of what is acceptable validation. Another important bottleneck in analytical method transfer is that different laboratories could use different facilities and instruments.

Reference:

http://www.nbchem.de/mediapool/120/1202675/data/110914_AMDVT_bn.pdf

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