Author: Nina Moreno

January 8, 2025

Modern Microbial Methods Supporting a Contamination Control Strategy

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...

See Blog

April 6, 2022

Initial Evaluation Roadmap for Modern Microbial Methods

This article presents the first four steps of an initial evaluation roadmap for modern microbial methods. It is the result of a collaboration among authors (listed below) from different industry working groups that joined forces in 2021 to support the...

See Blog