Validating rapid microbiology methods
Validation of alternative Microbiological Methods; the European pharmacopeia chapter 5.1.6 Alternate Methods for control of microbiological quality, and Rapid Microbial Method of the Japanese Pharmacopeia JP17, mainly.
However, the implementation of such kind of technologies remains difficult in user’s labs due to the numerous steps, limiting their usage despite the high added value of these methods in the quality control of products, process facilities and all together increasing patient safety.
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The validation assures equivalency of the new method to the reference method.
These have resulted in a significant increase in the methods available for the detection, enumeration, and identification of microorganisms in the laboratory.
This chapter provides a brief overview of the types of technologies available and the premise of how they work.
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The will provide attendees with an overview of the current landscape for rapid method validation strategies, implementation opportunities, and global regulatory approval processes.