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 ...
In this Pharma Matters Q&A, Amina Rahmoune of Nelson Labs evaluates and compares sterility testing in cleanrooms and isolators.
A panel of experts went over new regulatory requirements for contamination control and gave guidance on implementing a contamination control strategy in cell and gene therapy facilities at INTERPHEX ...
As demands for aseptic manufacturing increase, partnerships among solutions providers will become key to ensuring safe, ...
(MENAFN- GlobeNewsWire - Nasdaq) This course explores Annex 1's requirements, focusing on aseptic operations, CCS, and quality assurance. Attendees gain insights into regulatory expectations, ...
President & CEO Atif Sarfraz highlights key regulatory, operational, and human-factors shifts that are redefining cleanroom goggles in North America Cleanrooms are experiencing fundamental shifts in ...
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