News
22.04.2025 - Cosmetics
FDA identifies deficiencies – Burkholderia, Pseudomonas, Staphylococcus
Time and again the US Food and Drug Administration (FDA) identifies deviations from the Current Good Manufacturing Practice (CGMP) in pharmaceutical production facilities. Microbiological deviations often play a significant role in this context.
An example is the detection of Burkholderia and Pseudomonas species, with the source commonly being production water. Such contaminated water can have serious consequences in the manufacturing of pharmaceuticals. A thorough investigation of contamination sources (Root Cause Analysis) is necessary, along with effective corrective and preventive action (CAPA).
We support pharmaceutical manufacturers with the necessary microbiological tests according to Ph.Eur./USP of water, other raw materials, and finished pharmaceuticals. Furthermore, we provide comprehensive support on microbiological monitoring and all hygiene-related topics.
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Source:
https://www.bav-institut.de/de/news/Untersuchung-auf-Burkholderia-spp-in-Kosmetika-und-Arzneimitteln-sowie-Informationen-fuer-den-Praktiker