Automated Microbial Identifications: A comparison of USP and EP approaches

Microbial identification places an important role in pharmaceutical processing. Microbial identification can be defined as “microbial characterization by a limited spectrum of tests pre-chosen and appropriate to the problem being studied”.

Whilst the pharmaceutical microbiologist now faces a somewhat bewildering array of different test systems, once the selection has been made it is important, from a GMP perspective, that the system is validated. For this, both the United States Pharmacopeia and European Pharmacopeia offer some guidance. In general, the two approaches share more similarities than differences. There are, however, some aspects which are not in agreement. These are important to understand for those working for global pharmaceutical organizations, where inspections from different national regulators may occur.

To explore this further, Tim Sandle has written a paper for the AmericanPharmaceutical Review.

The reference is:

Sandle, T. (2013). Automated Microbial Identifications: A comparison of USP and EP approaches, American Pharmaceutical Review, 16 (4): 56-61

The paper can be viewed online here.

Posted by Tim Sandle