Chemistry Reference
In-Depth Information
8.4 elements oF Amt
Many interrelated components are necessary to achieve a successful AMT. As in any
validation process, documentation is pervasive; both for the process and the results.
Starting with a protocol and ending with a transfer report, everything must be docu-
mented for compliance purposes.
8.4.1 P
reAPProved
t
eSt
P
lAn
P
rotocol
Before implementing an AMT, an approved document must be in place that describes
both the general transfer process, as well as the acceptance criteria. This document
usually takes the form of a standard operating procedure (SOP) that describes the
details of the AMT protocol or test plan specific to the product and method. This
document should clearly define the scope and objective of the AMT, all of the
respective laboratories responsibilities, list all the methods that will be transferred,
and provide a rationale for any methods not included (i.e., the transfer waiver). It
should also include the selection of materials and samples to be used in the AMT.
Representative, homogeneous samples should be used that are identical for both
laboratories. Selection of proper materials or samples is very important; usually pre-
GMP materials or a “control lot” is chosen so that an out-of-specification (OOS)
investigation is not triggered. Remember that the purpose of the method transfer
is to assess method performance, not changes in samples or matrix. The protocol
should also include certificates of analysis (CoA) for any samples and reference
materials used.
Instrumentation and associated parameters should also be described. A best-case
scenario would have each laboratory using common instrumentation; if this is not the
case, and it rarely is, then the originator should consider running the method on instru-
mentation common to the receiving laboratory to identify any potential issues prior to
a formal AMT. Intermediate precision validation studies also commonly take instru-
ment differences into account. The protocol should also include a description of proce-
dures, requirements, and their rationale, as well as acceptance criteria as outlined later.
8.4.2 d
eScrIPtIon
of
m
ethod
/t
eSt
P
rocedureS
The method description should include not just the mechanics of performing the
method, but also validation data and any idiosyncrasies in the method. Any pre-
cautions that must be taken to ensure successful results should also be included in
the method description. The method should be written in a way as to ensure only
one possible interpretation, for example, volume-to-volume (v/v) if volume mea-
surements are made, etc. Clear equations and calculations, if appropriate, should be
specified.
8.4.3 d
eScrIPtIon
And
r
AtIonAle
of
t
eSt
r
eQuIrementS
Specific information on the number of lots, replicates, and injections, among other
parameters, should also be included in the method description, as well as the rationale
