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 ...

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

A Contamination Control Strategy (CCS) identifies and evaluates contamination risks, explores mitigation options, and sets out plans for corrective and preventive actions. Its implementation addresses ...

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, ...

As demands for aseptic manufacturing increase, partnerships among solutions providers will become key to ensuring safe, ...

The 2023 revision of Annex 1 of the European Union’s good manufacturing practice (GMP) guidelines 1 represents a fundamental shift in expectations for sterile manufacturing. Reg ...

Learn how ready-to-use vials and cartridges can aid in GMP Annex 1 Implementation and streamline compliance with EU ...

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 ...

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 ...

PSC Biotech partners with Blue Ocean Robotics to distribute the UVD Robot Pharma delivering autonomous UV C disinfection for ...

Regulatory pressure is another catalyst. The revised EU GMP Annex 1, which took effect in recent years, introduced stricter requirements around contamination control strategies, pushing drugmakers to ...