Chemistry Reference
In-Depth Information
9
Implementing New
Technology in a
Regulated Environment
9.1 IntroductIon
Over the course of a drug product's lifetime (as many as 15 to 20 years or more),
many significant advances in technology will occur. Implementing new analytical
techniques (e.g., capillary electrophoresis) or advances in existing technology (e.g.,
sub-2-mm particle columns for HPLC) can significantly impact business practices
(return on investment) and product quality. However, in a regulated laboratory,
implementing new technology can present many challenges. This chapter discusses
some industry-accepted practices for implementing new technology, FDA guidance
available on the subject, and the process to consider when adopting new technology
for use in approved, standard, or validated analytical methods.
9.2 cHAnges to An Approved metHod
First, a disclaimer: This chapter is a summary of accepted practice and interpretation
of regulatory guidelines from the authors' experience, as well as the authors' opin-
ions derived from an informal poll of industry and regulatory resources; regulating
change is something of a “gray” area, but there is guidance available. Please consult
with the proper authorities before implementing any plan based on this chapter. The
bottom line, as always, is that good, justifiable science is always the desired solution,
and it is a good idea to have standard operating procedures (SOPs) in place to follow.
Standard or validated methods can be found in a number of places, for example,
the United States Pharmacopeia (USP), or in the Official Methods of Analysis of the
Association of Official Analytical Chemists (AOAC). Methods in both new (NDA)
and abbreviated (ANDA) drug applications are also considered standard validated
methods.
To use a standard method “as is” for the first time, a laboratory must perform a
verification to demonstrate that both instrument and method performance criteria
are met [1-3]. However, to implement new technology, an adjustment, or a modifica-
tion or change, to a standard method might be needed.
In April of 2004, the FDA published a guidance that makes recommendations to hold-
ers of both NDAs and ANDAs that desire to make postapproval changes [4]. It is impor-
tant that analysts refer to this guidance to determine what type of changes-being-effected
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