Explore key questions on contamination control strategies to support regulatory compliance and risk management in ...

Advanced biologics and patient-specific therapies reduce opportunities for terminal sterilization, elevating proactive microbial risk control and integrating QC microbiology into CCS authorship, risk ...

Pharmaceutical manufacturers engaged in biotechnology, pharmaceutical, medical device, home and personal care, and other related manufacturing industries need to be meticulous in creating and ...

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 ...

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 ...

Environmental monitoring requirements in ATMP facilities, addressing regulatory compliance, GMP standards, and 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 ...

Viral safety will be a major challenge for the CGT industry for the foreseeable future, according to new analysis.

AUSTIN, Texas, April 07, 2026 (GLOBE NEWSWIRE) -- AINewsWire Editorial Coverage: Pharmaceutical manufacturing is undergoing a structural shift as regulators demand higher standards for contamination ...

ZHONGSHAN CITY, GUANGDONG PROVINCE, CHINA, March 19, 2026 /EINPresswire.com/ — In industries where a single particle can compromise an entire production batch ...