On March 30, 2015, the European Commission published the new version of Annex 15 "Qualification and Validation" of EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use. The Annex contains qualification and validation principles applicable to the facilities, equipment, utilities, and processes used for the manufacture of medicinal products manufacturing and may also be used as supplementary optional guidance for active substances. The new version will become operational on October 1, 2015.
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