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Best practice of worldwide product variations …
Best practice of worldwide product variations regarding planning, conduct and implementation Wissenschaftliche Pr fungsarbeit zur Erlangung des Titels Master of Drug Regulatory Affairs der Mathematisch-Naturwissenschaftlichen Fakult t der Rheinischen Friedrich-Wilhelms-Universit t Bonn vorgelegt von Dr. Maike Melullis aus Hamburg Bonn 2015 Betreuer und 1. Referent: Dr. Mohamed Baccouche Zweiter Referent: Dr. Peter BachmannList of Figures I List of Figures Figure 1 - Structure of Common technical document (CTD) .. 26 Figure 2 - Content and Structure of ACTD .. 27 Figure 3 - internal departments involved in compilation of variation documentation .. 32 Figure 4 - internal departments to be informed on the approval of variations .. 40 List of Abbreviations and Acronyms II List of Abbreviations and Acronyms ACTD ASEAN Common technical Document API Active Pharmaceutical Ingredient ASEAN Association of the Southeast Asian Nations CC Change Control CFR Code of Federal Regulations CIS Commonwealth of independent states CMC chemistry, manufacturing and control CPP Certificate of Pharmaceutical product CTD Common Technical Document EP European Pharmacopeia EU European Union FDA Food and Drug Administration GCC Gulf Cooperation Cou
Best practice of worldwide product variations regarding planning, conduct and implementation Wissenschaftliche Prüfungsarbeit zur Erlangung des Titels
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