You know why is Microbial Identification Important?

Harmful bacteria and fungi can contaminate raw materials, production facilities, and branded products. Regulatory expectations include accurate identification of environmental isolates to support active environmental monitoring programs within pharmaceutical manufacturing environments as part of cGMP, and to implement accurate Corrective and Preventive Actions (CAPAs) for products and processes to reduce the risk of contamination. The US, European, and Japanese Pharmacopeia guidelines recommend genotypic microbial identification of bacteria and fungi at the species level. The comparative gene sequence analysis of ribosomal DNA (rDNA) has been shown to have the highest accuracy of microbial identification system technologies and has been considered the gold standard for microbial identification for over a decade.