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 ...

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 ...

Understand cGMP requirements for portable environmental monitoring to support contamination control in pharmaceutical cleanrooms.