The update to EU GMP Annex 1 offers opportunities in aseptic operations by aligning with global standards and enhancing contamination control strategies. It addresses sterile manufacturing, cleanroom ...

Contract development and manufacturing organizations can assist sponsor company is ensuring sterility assurance in alignment with the EU’s Annex 1 guidelines. The 2023 revision of Annex 1 of the ...

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 ...

AINewsWire Editorial Coverage: Pharmaceutical manufacturing is undergoing a structural shift as regulators demand higher standards for contamination control, data integrity and operational ...

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

TechForce Robotics contributes to this evolution by embedding AI-driven SOP intelligence and real-time monitoring into its robotic systems. This enables compliance to function as an integrated, ...

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 ...

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 ...

A former US Food and Drug Administration (FDA) official said the agency’s draft guidance on setting up inspection testing programs for detecting visible particles in injectable drugs is meant to ...