EDQM held a symposium on microbiology to gather industry feedback on alternative testing methods for microbiological control and sterilization processes.
On October 10–11, 2017, the European Directorate for the Quality of Medicines & Healthcare (EDQM) held a symposium to discuss trends and innovation in microbiology. Pharmacopeial approaches and regulatory requirements were addressed. Participants of the symposium agreed that current pharmacopeial standards worldwide sufficiently covered alternative methods to detect, enumerate, and identify microorganisms.
Topics discussed at the symposium included modern methods for microbiological control, sterilization, biological indicators, rapid microbiological methods, and control methods for cell therapy products and pharmaceutical water. Acceptance of new technologies was also discussed.
Source:
EDQMDrug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
AES Clean Technology Launches Next-Generation OSM Utility Solution for Cleanrooms at INTERPHEX 2025
April 2nd 2025Officially launched at INTERPHEX 2025, the Omni ASCENT is a next-generation off-site manufactured vertical utility solution that offers optimized cleanroom flexibility and efficiency.