Cleanroom laboratories manufacturing sterile medicinal products in the European Union (EU) must make critical changes by August 25, 2023 to ensure Annex 1 Regulation compliance. This is a substantial update to the initial version released in 2008 and provides comprehensive guidance for manufacturers, including the design and control of facilities, equipment, systems, and procedures used for the manufacture of all sterile products to ensure that microbial, particulate, and endotoxin/pyrog
Cleanroom laboratories manufacturing sterile medicinal products in the European Union (EU) must make critical changes by August 25, 2023 to ensure Annex 1 Regulation compliance. This is a substantial update to the initial version released in 2008 and provides comprehensive guidance for manufacturers, including the design and control of facilities, equipment, systems, and procedures used for the manufacture of all sterile products to ensure that microbial, particulate, and endotoxin/pyrog