Validating rapid microbiology methods
Because many RMM technologies consist of a combination of instrumentation, software, consumables and reagents, in addition to specific detection, quantitative or identification methodologies, it is important to develop a comprehensive and holistic approach to the validation process to ensure that the entire RMM system is suitable for its intended use.
The following sections provide an overview of how to design a meaningful validation program in order to effectively demonstrate that the new RMM is equivalent to, or better than, the existing method you intend to replace.
Of all industrial microbiology sectors the pharmaceutical sector is perhaps the one most restricted, guided and determined by regulatory requirements.
This is applicable not solely to what and when samples ought to be tested, but also what method should be used.
Method validation is the process used to confirm that an analytical procedure employed for a specific test is reliable, reproducible and suitable for its intended purpose.
All analytical methods need to be validated prior to their introduction into routine use, and this is especially true for novel technology platforms, such as rapid microbiological methods (RMMs).
When companies evaluate rapid methods for use in their microbial quality control testing, one area that can often cause confusion is the validation requirements of the various methods.