Chemistry Reference
In-Depth Information
8.3.1 c
omPArAtIve
t
eStIng
Comparative testing is the most common AMT option used. It is accomplished when
two or more laboratories perform a preapproved protocol that details the criteria used
to determine whether or not the receiving laboratory is qualified to use the method
being transferred. The data resulting from the joint exercise is compared against a set
of predetermined acceptance criteria. Comparative testing can also be used in other
postapproval situations involving additional manufacturing sites or contract labora-
tories. In general, comparative testing is most often used for late-stage methods and
the transfer of more complex methods.
8.3.2 c
o
-v
AlIdAtIon
between
l
AborAtorIeS
Traditionally, a validated method is a prerequisite to AMT. However, another option
for AMT is to involve the receiving laboratory from the beginning in the actual
validation of the method to be transferred. By completing a co-validation study, the
receiving laboratory is considered qualified to perform the method for release test-
ing. To perform this transfer option, the receiving laboratory must be involved in
identifying the intermediate precision validation parameters to be evaluated and the
experimental design [11]. By including data from all laboratories involved in the
study, it is possible to have the validation report stand as proof of AMT.
8.3.3 m
ethod
v
AlIdAtIon
And
r
evAlIdAtIon
A third option for AMT is method validation and revalidation. This option involves
the receiving laboratory repeating some or all of the originating laboratory's valida-
tion experiments. As discussed previously, by completing any type of validation study,
the receiving laboratory is considered qualified to perform routine release testing.
8.3.4 t
rAnSfer
w
AIver
In addition to the times when a formal AMT is not needed (e.g., compendia methods),
certain other situations might also warrant omitting a formal AMT. They include
• The receiving laboratory is already testing the product and is thoroughly
familiar with the procedures.
• A method or procedure exists for a comparable dosage form relative to the
existing product.
• The analytical method (or one very similar) is already in use.
• A new method that involves changes that do not signiicantly alter the use
of the method.
• The personnel accompany the transfer of the method from one laboratory
to another.
When a transfer waiver is indicated, the receiving laboratory can use the method
without generating any comparative data. However, the reasons for the waiver must
be documented.
