USP <1113> Microbial Identification - In Process Revision including a title change

The USP chapter<1113> with the title "Microbial Identification" is currently on status "In-Process-Revision" according to the Pharmacopeial Forum 36 number 6. The chapter is being revised including a title change to "Microbial Characterization, Identification and Strain Typing". The chapter addresses general information on available methods of microbial identification, their methods for use and the verification of these methods.

The proposed revision suggests to consider the current development and changes in microbial characterisation especially of modern microbiological methods and actual scientific developments e.g. regarding isolation of pure cultures of stressed micro organisms. Furthermore, the revised version refers to the importance of microbial characterisation for many risk assessments.

Beyond this, the draft accentuates that strain level identification can be useful in investigation to determine the source of  a micro organism. Accordingly, all subchapters are changed and the subchapters from "Polyphasic Identification" to "Objective of a Microbial Identification Programme" were deleted without replacement.

We can notice that the parts of Chapter <1113> which specified by name concrete microbiological systems and media were deleted. Thereby, a more neutral keeping of the recommendations and information related to systems and culture media manufacturers has been accomplished.

Chapter <1113>  responds to phenotypic methods for identification as well as genotypic methods and refers to the benefits of these methods to enable the microbiologist to make scientific based decisions regarding product risk, to identify changes in environmental microflora (phenotypical methods) or relating to critical microbiological investigations, e.g.  in case of  product failure.

The ECA Education Course "Microbiological Best Laboratory Practices" in Berlin, Germany, from 23-25 February 2011 covers, amongst others, the topics of microbial identification with lectures from speakers with a broad experience in pharmaceutical microbiology.

Axel Schroeder
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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