This article discusses how modern microbial methods (also known as rapid microbiological methods or alternative methods) can support a contamination control strategy, which is a requirement of EU GMP Annex 1, Manufacture of Sterile Medicinal Products. The article is the result of a collaboration among authors (listed below) from different industry working groups that joined forces in 2021 to support the awareness and adoption of modern microbial methods. Nina Moreno, Global Segment Director for Sterility Assurance at Nelson Labs, was one of the authors.
Authors: Allison Scott, Amanda McFarland, Jon Kallay, Meghan Provenzano, Timothy Cser, and Nina Moreno.
