The EU’s eagerly anticipated revision of its good manufacturing practice (GMP) Annex 1 for sterile drug products was released on Thursday after 14 years of development. The revised requirements, which ...
Annex 1 reframes sterility assurance from prescriptive checklists to a performance-based, prevention-first contamination control strategy spanning the full product life cycle. Sponsor gaps—limited ...
In this free webinar, see how environmental monitoring in pharma supports contamination control, inspection readiness and a demonstrable state of control. Attendees will learn how to design a ...
Environmental monitoring requirements in ATMP facilities, addressing regulatory compliance, GMP standards, and contamination ...
The FDA and EMA have set out updated regulatory agendas that will shape biologics manufacturing standards in coming years. The FDA’s Center for Biologics Evaluation and Research (CBER) 2026 agenda ...
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 ...
AUSTIN, Texas, April 07, 2026 (GLOBE NEWSWIRE) -- AINewsWire Editorial Coverage: Pharmaceutical manufacturing is undergoing a structural shift as regulators demand higher standards for contamination ...
Bio: Don Singer is a Fellow in the American Society for Quality and formerly a GSK Senior Fellow. Don has been Chair of the USP General Chapters - Microbiology Committee of Experts and a member since ...
AUSTIN, Texas, April 09, 2026 (GLOBE NEWSWIRE) -- AINewsWire Editorial Coverage: Pharmaceutical manufacturing is entering a period of structural transformation as regulators impose increasingly ...
Detailed price information for Serve Robotics Inc (SERV-Q) from The Globe and Mail including charting and trades.
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