Benefits and Limitations of Species Identification

Rubrik: Analytik

(Treffer aus pharmind, Nr. 03, Seite 282 (2025))

Mertens F | Steinhauer K

Benefits and Limitations of Species Identification / Mertens and Steinhauer | Species Identification · Mertens F, Steinhauer K · VAAM-Fachgruppe Qualitätsmanagement und bactologicum GmbH; University of Applied Sciences Kiel; VAAM-Fachgruppe Qualitätsmanagement
GMP Production Hygiene Validation Identification Contaminants Pharmaceutical drugs need to be safe, i.e. they must not pose an infection risk for the patients. In production processes effective contamination control strategies (CCS) are key, and microbiological testing is performed at multiple stages. For products meant to be sterile, the absence of any microorganism is a non-negotiable requirement. For non-sterile products the situation is by far not as clear. To ensure safety of products, European Pharmacopeia (EP) therefore requires the absence of certain specified microorganisms in products [ 1 ] and in raw materials (respective monographs in EP 5.1.4). Depending on the type ...