Validating rapid micro methods Xcams4 free vidio chat

Of all industrial microbiology sectors the pharmaceutical sector is perhaps the one most restricted, guided and determined by regulatory requirements.

Among other stakeholders, the validation process requires involvement of quality assurance personnel and external regulatory agencies if a license change is required.

The following are some of the processes involved in validating growth-based and alternative rapid methods.

Miller, Ph D Microbiology Consultants, LLC From 2010 to 2013, European Pharmaceutical Review published a very successful series on rapid microbiological methods (RMM) that included hot topics such as the European Medicines Agency’s and US Food and Drug Administration’s expectations, implementation strategies, scientific principles behind the technologies and validation.

The final article of the 2012 series introduced the United States Pharmacopeia’s (USP’s) plan to revise informational chapter was published in the second supplement to USP38/NF33 with an official date of 1st December 2015.

These changes can impact training plans and SOPs and increase the validation requirements.

Whatever method is selected, it must be validated before moving into routine use.

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.

For example, methods that are growth-based have different validation requirements to methods that would be considered alternative, and within the alternative methods there are differences based on the scientific method employed.

These types of methods can be classified as “automated compendial,” since they simply automate the existing method and provide results in colony forming units (CFUs).

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