The New Annex 1 Regulations – Why is it important and how can we help?

The New Annex 1 Regulations – Why is it important and how can we help?

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Annex 1 of EudraLex “The Rules Governing Medicinal Products in the European Union” forms part of Volume 4 of the European guidelines and covers the manufacture and release of sterile products. With the recent update, Ecolab has identified how this will impact the cleaning and disinfection procedures undertaken within the cleanroom environment, and discusses some of these impacts here.
URL
https://www.ecolab.com/articles/2022/12/the-new-annex-1-regulations
Ecolab Life SciencesEcolab Life Sciences offers unparalleled cleaning and advanced contamination control expertise to pharmaceutical and personal care manufacturers across the globe. We deliver more than quality cleaning chemistry. We bring enhanced value to customers, helping optimise production performance and mitigate risk. Enhanced value: Our expertise applied to our cleaning and advanced contamination control solutions means customers have access to a comprehensive portfolio of high-quality cleaning and disinfection chemistry, equipment, and Bioquell vaporized hydrogen peroxide decontamination. Optimized production performance: Our expertise across a wide range of critical manufacturing applications helps customers move toward maximum production uptime and productivity. Mitigated risk: Our expertise and global scale applied across our customers’ contamination-control operations help assist with business continuity through the worldwide availability of our solutions and knowledge of region-specific quality and regulatory requirements.

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