Transcription of Technical Report No. 65
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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.
Medicinal Products (IMPs) and commercial products in implementing the ICH guidelines on Phar-maceutical Development (ICH Q8, Q11), Quality Risk Management (ICH Q9) and Pharmaceutical Quality Systems (ICH Q10). The PCMO program facilitates communication among the experts from industry, university and regula-
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