bioQTForum (http://bioQTForum) has posted a new article on their website entitled "Evaluating Library Databases for Microbial ID - Critical Aspects and Recommendations.” The key focus of this review is to present questions to ask manufacturers and contract laboratory services about their microbial identification libraries and analytical tools used for microbial identifications. The article discusses the attributes and limitations of different methodologies in analyzing results to determine an ID. Equally important in a highly regulated industry, cGMP, compliance and validation strategies for library database entries and maintenance are explored. I have also added a link to the article on our RMM References Page (http://rapidmicromethods.com/files/references.html).
- Scientific Principles
- _Growth-based Methods
- _Viability Staining and Laser Excitation
- _Detection of Cellular Components
- _Optical Spectroscopy
- _Nucleic Acid Amplification
- _MEMs
- Product Matrix
- Validate
- Regulatory
- _Annex 1 Revision
- _Rapid Sterility Testing of ATMPs
- _Changing Acceptance Levels
- _US Food and Drug Administration (FDA)
- _European Medicines Agency (EMA)
- _Australia TGA
- _Japan PMDA
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