Industry Guidelines

MEI provides strategic genetic based microbial identification and differentiation services, positioning our Clients to meet critical industrial guidelines. Our methods and approaches are consistent both with well established 21 CFR 210 & 211 drug manufacturing cGMP guidelines, as well as FDA’s new “Process Analytical Technologies (PAT)” initiative. MEI’s laboratories operate under cGMP guidelines, and are ISO-17025 2005 accredited. MEI is appropriately equipped, understands validation requirements, and is compliant with FDA requirements in providing microbial identification, genetic sub-typing (fingerprinting), microbial contamination tracking, and environmental monitoring support services for the Pharmaceutical and Biotechnology industry.

Sterility testing is already an integral part of current pharmaceutical industry good manufacturing practice, with CFR 211.167(a) requiring appropriate laboratory testing to determine sterility requirement conformance. The FDA recommends that sterility test isolates should be identified to the species level, and that microbiological monitoring data should be reviewed to determine if the organism is also found in laboratory and production environments, personnel, or product bioburden. They have further recommended the value of advanced (e.g., genetic based) identification methods for these purposes.

The FDA has also recently released new guidance documents for the pharmaceutical industry for “Sterile Drug Products Produced by Aseptic Processing”. The guidelines stress the importance of having accurate methods to identify microbial contamination and enable effective environmental monitoring programs. From their marked success in other industry sectors, they state that effective identification and monitoring are best achieved through the use of genetic-based molecular identification methods.