Effects Of Annex 1 Revisions On Manufacturing Operations: An Overview Of Updated Best PracticesThe revisions to European Union (EU) Annex 1 set the stage for the future direction of the pharmaceutical/biotechnology industry. This document is one of the main EU regulatory guidelines for Risk Management and Contamination Control (Eudralex Volume 4, EU Guidelines to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use, Annex 1: Manufacture of Sterile Medicinal Products) and also serves as the blueprint for the strategies and policies implemented by the many pharmaceutical/biotechnology companies in the United States (US), as US companies frequently consider the EU market.

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