Cleanroom laboratories manufacturing sterile medicinal products in the European Union (EU) must make critical changes by 25 August 2023 to ensure Annex 1 Regulation compliance and Beckman Coulter Life Sciences is continuing its commitment to providing laboratories of all sizes with tailored support to meet the evolving list of regional and global compliance requirements.
The upcoming Annex 1 deadline is for 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.
“At 58 pages and 293 paragraphs, we understand laboratory professionals have questions about this updated and broad regulation,” said Anurag Tandon, Global Vice President of Quality Control and Bio-Manufacturing. “This new era of compliance will raise questions, and we are committed to working with laboratories of all sizes to clarify and provide answers to complex questions as we continue to lead the way in providing resources and consultations for laboratories to ensure a seamless compliance transition.”
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.
“Solutions from Beckman Coulter Life Sciences for analysing total organic carbon, environmental monitoring and particle counting are used every day around the world to help ensure quality and safety in diverse applications,” Tandon continued. “We share a name with measurement principles that drive particle counting and characterisation technology – The Coulter Principle – and are a trusted resource for instruments delivering critical data to researchers, formulation development scientists, and GMP-regulated quality control departments around the world.”
MET ONE 3400+ Series portable air particle counters (pictured above) from Beckman Coulter Life Sciences enable laboratories 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 analyser is specifically designed to help demonstrate compliance to the pharmacopeial requirements for TOC and conductivity for purified water and Water for Injection (WFI) systems.
From analysing TOC to particle counting and characterization, Beckman Coulter Life Sciences is able to help with resources and in-person or virtual consultations. View the company’s online resources here - https://www.beckman.com/resources/industry-standards/eu-gmp-annex-1