Advanced biologics and patient-specific therapies reduce opportunities for terminal sterilization, elevating proactive microbial risk control and integrating QC microbiology into CCS authorship, risk ...
Correction: This article was edited on 15 September 2022 to correct Jorg Zimmermann's title. Sterile drug manufacturers should start preparing a gap analysis to identify what needs to be done to ...
Dublin, April 10, 2026 (GLOBE NEWSWIRE)-- The "New EU GMP Annex 1: Compliant Sterile Medicinal Products (May 19th - May 23rd, 2026)" training has been added to ResearchAndMarkets.com's offering. The ...
Understand cGMP requirements for portable environmental monitoring to support contamination control in pharmaceutical cleanrooms.
A new modification of the EU GMP Annex 1 regulatory standard for sterile drug products was announced in August 2022, substituting the most recent 2020 draft and the previous 2008 revision. The new ...