Chemistry Reference
In-Depth Information
8
Analytical Method
Transfer
8.1 IntroductIon
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 valida-
tion of robust methods and strict adherence to well-documented standard operating
procedures (SOPs) is the best way to ensure the ultimate success of the method. This
chapter examines the analytical method transfer process, including protocol, docu-
mentation, and some possible chromatographic pitfalls to avoid.
8.2 terms, deFInItIons, And responsIbIlItIes
In a regulated environment, it is rare for the laboratory that develops and validates
a method to perform routine sample testing. Instead, once developed and validated
(in the originator, or “sending” laboratory), methods are commonly transferred to
another laboratory (the “receiving” laboratory) for implementation. However, the
receiving laboratory must still be able to get the same results, within experimen-
tal error, as the originating laboratory. The process that establishes documented
evidence that the analytical method works as well in the receiving laboratory as
in the originator's lab, or the transferring laboratory, is called
analytical method
transfer
(AMT). The topic of AMT has been addressed by both the American
Association of Pharmaceutical Scientists (AAPS: in collaboration with the FDA,
EU regulatory authorities) and the Pharmaceutical Research and Manufacturers of
America (PhRMA) [1-3]. The PhRMA activities resulted in what is referred to as
an Acceptable Analytical Practice (AAP) document that serves as a suitable first-
step guidance document for AMT [3]. In their various publications, both the AAPS
and PhRMA have described the AMT process in some detail, and this chapter dis-
cusses these publications, some of the available guidance, and introduces a few addi-
tional thoughts concerning potential chromatographic pitfalls. However, as always,
the reader is encouraged to consult these and other references for more information
[4-8]. In essence, the AMT process is what qualifies a laboratory to use an analyti-
cal testing procedure, and regulators want documented proof that this process was
completed successfully; only then can the receiving laboratory obtain GMP “report-
able data” from their laboratory results. A typical AMT would take place between
a research group that developed the method and a quality control group responsible
for releasing finished product, although any time information moves from one group
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