GXP

Microbial Identification strategy for pharmaceutical microbiology

Microbial identification represents an important part of the microbiology function. This includes screening products for objectionable organisms, profiling the environmental microbiota, and investigating out-of-limits events with a view to assigning a probable point of origin. In deciding what and when (and subsequently to which level) to identify, and by the way of which methods, requires an identification strategy. This is a document each microbiology laboratory should develop.

Many parts of pharmaceutical microbiology are outlined in compendia or in guidance documents issued by regulators; included within these are the importance of bioburden assessments of intermediate and finished products, and the need to monitor the environment using standard environmental monitoring methods. What is less clear is with microbial identification. For identification there are established and emerging methods, based around the microbial phenotype or genotype, yet the choice between systems is not straightforward and the selection depends, in part, on what needs to be identified. Deciding which types of samples to identify; which level of identification is appropriate (morphology, genus, or species); and what can be done with the collected information needs careful thought. A further decision point is whether the testing laboratory carries out the testing ‘in house’ or contracts out the function. This article addresses these points and provides a basis of the microbiologist in each pharmaceutical or healthcare organization to develop a microbial identification strategy.

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