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Technical Report No. 65

BethesdaTowers4350 EastWestHighwaySuite200 Bethesda, MD20814 USATel:1 (301)656-5900 Fax:1 Report No. 65 technology TransferParadigm Change in Manufacturing technology transfer Technical Report TeamAuthorsMirko Gabriele, EMPHA, Patheon Italia Spa, (Team Leader)Derek Blaettler, F. Hoffman-LaRoche, Elyath, Genzyme CorporationStephan Krause, , MedImmuneAndrea Morelli, Kedrion BiopharmaChittoor Narahari, GlaxoSmithKlineJamie Rogers, Biogen IdecVictor Sanchez, Pharma-Bio Serv Seymour, Biogen IdecYi Xie, , Eli Lilly and CompanyWayland Rushing, , Analytical Bio-Chemistry Laboratories, Wohlpart, , Merck & content and views expressed in this Technical Report are the result of a consensus achieved by the authoring task force and are not necessarily views of the organizations they TransferTechnical Report No. 65 ISBN: 978-0-939459-68-1 2014 Parenteral Drug Association, Inc.

Pharmaceutical technology transfer consists of planned and controlled actions that are based on well- defined acceptance criteria to convey a manufacturing process, analytical method, packaging com ponent, or any other step or process along the pharmaceutical drug lifecycle from an originator site,

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