Identification Methods for Bacteria and Fungi

Vikki Warren, Identification Services Manager The revised Annex 1 came into force on 25 August 2023. These guidelines apply to sterile medicinal product manufacture, and aim to ensure that microbial, particulate and endotoxin/pyrogen contamination is prevented in the final product. This is obviously an essential goal when it comes to sterile medicinal products, so the application of the guidelines to create an effective contamination control strategy is of paramount importance. With respect to the identification of microorganisms as part of the environmental monitoring programme, Annex 1 states that microorganisms detected in …