ABSTRACT
Numerous microbiological methods in use today date
back to the time of Louis Pasteur. These methods are still
useful and effective but there is a substantial interest in
the development and use of more modern techniques. In
fact most pharmacopeial microbiological methods in USP,
EP, and JP are closer to the methods of Pasteur’s time and
are the so-called classical methods. Advances in method-
ologies and instrumentation should be incorporated in
the pharmacopeial methods that are cited by the FDA for
compliance purposes. Microbiological methods,
especially if intended for replacement of more conven-
tional approaches require validation. If the new methods
that are desirable because of advantages speed, accuracy,
specificity, and generation of more quantitative data are
to replace the pharmacopeial methods, then they also
have to be shown to be equivalent (equal or better) than
the pharmacopeial methods. This situation exists in
Europe, Japan and in the U.S.A., where regulatory
agencies will accept alternative methods to the pharma-
copeial methods for compliance purposes.
