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Critical Utilities 2020 - Annex 1 and its Comparison to Critical Utilities Compendial mandates: What does it all imply to the industry



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Annex 1 is to be released formally in the very near future. This guidance for the Manufacture of Sterile Products is a regulatory enforceable document which is a de facto mandatory standard.
Any company marketing, selling, producing, manufacturing, or compounding pharmaceuticals, APIs, and biologics for the European Community will be subject to scrutiny by European regulators, regardless of your country of origin, for production and manufacturing.
Description of Annex 1 by paragraph
Assessment of Annex 1 in relation to existing Pharmacopeias
A recognized worldwide expert, with over 40 years’ experience, in high purity, ultrapure, reclaim and recycle water systems, and Total Organic Carbon

Last modified: 2020-11-17 20:16:35