Ensure EU GMP Annex 1 compliance before August 2023 deadline
Beckman Coulter Life Sciences offers tailored solutions for EU GMP compliance and beyond
25 Jul 2023Industry news
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/pyrogen contamination is prevented.
Key focus areas in the revised regulation include applying the principles of Quality Risk Management (QRM), ensuring continuous environmental monitoring, online total organic carbon (TOC) monitoring, and an increased emphasis on the importance of having a robust Contamination Control Strategy (CCS) in place. The classification of cleanrooms and environmental monitoring is also increasingly important throughout the update.
MET ONE 3400+ Series portable air particle counters from Beckman Coulter Life Sciences enable labs to monitor air cleanliness in compliance with EU GMP Annex 1 Regulation, ISO 14644, and FDA CGMP, with features that include plug-and-play networking and customized electronic SOP maps.
Annex 1 Regulation also includes a focus on utilities, including water systems. The ANATEL PAT700 TOC analyzer is specifically designed to help demonstrate compliance to the pharmacopeial requirements for TOC and conductivity for purified water and Water for Injection (WFI) systems.