Michael E. Swartz | Authors

One issue that has become clear to us throughout courses, workshops, seminars, and various talks on the subject of method validation, is that while many people talk the language, sometimes the individual method validation terms mean different things to different people. While the actual protocols, or experimental details used to measure or evaluate method validation can vary, it's a good idea to have a common understanding of the underlying terms. In this month's installment of "Validation Viewpoint," we have compiled glossary of method validation terms as they pertain to chromatography.

November 2006. The objective of a formal method transfer is to ensure that the receiving laboratory is well trained, qualified to run the method in question, and gets the same results - within experimental error - as the initiating laboratory. The development and validation of robust methods and strict adherence to well documented standard operating procedures is the best way to ensure the ultimate success of the method. This installment of "Validation Viewpoint" examines the analytical method transfer process, including protocol, documentation, and some possible chromatographic pitfalls to avoid.

After having collected some industry accepted practices for implementing new LC technology, the duo discuss FDA guidance available on the subject with respect to LC, and using some recently introduced LC technology.

The authors define robustness, instroduce a few approaches to designing a robustness study, and discuss data analysis necessary to help ensure successful method implementation and transfer as a part of method validation protocol.

The authors take a look at three recently published documents in the validation literature from groups working to (hopefully!) clear up some of the potential for confusion.