Validating rapid micro methods
With the development of novel medicinal preparations, such as ATMPs and other short-lived products, the need to quickly and accurately detect contamination is of utmost importance.
Although more and more companies around the globe have embraced rapid technologies and have validated and gained approval for their routine use, regulatory policies, compendial guidance and industry best practices for validation continue to evolve.
The pharmaceutical industry, however, has not been as quick to embrace rapid microbiology despite the potential advantages.
Faster microbiology test results would provide better control over the manufacturing process.
The current compendial tests are also simple to execute and the results are easy to understand (colonies on a plate or turbidity in a liquid culture) even for a non-microbiologist.
Microbiological Test Methods Microbiological tests for pharmaceuticals fall into several categories.
This article will provide an overview of microbiology testing in the pharmaceutical industry and will look at where rapid microbiological testing methods could fit into the manufacturing process.