Chemistry Reference
In-Depth Information
tAble 8.1
sending laboratory responsibilities and
receiving laboratory provisions
originating/transferring
laboratory responsibilities
receiving laboratory
provides
Create the transfer protocol
Qualified instrumentation
Execute training
Personnel
Assist in analysis
Systems
Acceptance criteria
Protocol execution
Note:
Both laboratories are responsible for issuing the final report.
to another (e.g., to a contract laboratory), proper AMT should be observed. Both the
originator and the receiving laboratories have certain responsibilities and must make
certain provisions in the AMT process; these are listed in Table 8.1.
Before initiating AMT, there are a few pretransfer activities that must take place.
If not previously involved with the method, the receiving laboratory should have
an opportunity to review the method prior to the transfer, and to actually run the
method to identify any potential issues that may need to be resolved prior to finaliz-
ing the transfer protocol. The originator should provide the receiving laboratory with
all the validation results, including robustness study results, as well as documented
training.
8.3 AnAlytIcAl metHod trAnsFer optIons
Similar to many things in life, a little up-front investment prevents a multitude of
problems later on. The foundation of a successful AMT is a qualified instrument
(Chapter 2), properly developed and validated method or procedure (Chapters 3 and
4), and a good robustness study (Chapter 5) is certainly a development and valida-
tion cornerstone [9-12]. The AMT process needs to involve more than the receiving
laboratory obtaining expected results from a representative sample, because a single
test is no indication of how a method will perform over time. A single test also does
not generate the data necessary to perform proper statistical evaluations, and com-
pensating errors could also be masked. A formal AMT is not always necessary, how-
ever. Compendia methods (e.g., Karl Fisher, residue on ignition), in-process tests, or
research methods do not require a formal transfer. In the latter two cases, a system
suitability test is employed as the basis for the transfer.
There are several different AMT options. These include comparative testing,
complete or partial method validation or revalidation, co-validation between the
two laboratories, and the omission of a formal transfer, sometimes called a
transfer
waiver
. The choice of which option to use depends on the stage of development the
method is being used in (early or late stage), the type of method (i.e., compendia
versus noncompendia, simple or complex), and the experience and capabilities of the
laboratory personnel.
