International Workshop on Qualification and Control of Impurities
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International Workshop on Qualification and Control of Impurities* Leon A.G.J.M Van Aerts, Peter Kasper, Olaf Queckenberg, Lutz Mueller and Anthony Cartwright Drug Information Journal 2006 40: 155 DOI: 10.1177/009286150604000204 The online version of this article can be found at: http://dij.sagepub.com/content/40/2/155
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Drug Information Association
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Leon A.G.J.M Von Aerts, PhD Centre for Bioloeical Medicine; and Mezical Technology. National Institute for Public Health and the Environment, Bilthoven, The Netherlands Peter Kasper, PhD Federal Institute for Drugs and Medical Devices, Bonn, Germany
Olaf Queckenberg, PhD Bayer Healthcare AG, Leverkusen, Germany
Lutz Mueller, PhD F. Hoffmann-La Roche AG, Basel, Switzerland
Anthony Cartwright, FRPharmS Global Regulatory Solutions Ltd., S t . Albans. United Kingdom The DIA International Workshop 'Impurities and Degradation ProductsBiological Qualification. Process Capabilitj and Analytical Control," was held September 23 and 2 4 , 2004, in Basel, Switzerland.
Key Words Impurities; Genotoxicity; Threshold of toxicological concern (TTC); Structure activity relationship (SAR); Process chemistry Correspondence Address Leon van Aerts. Centre for Biological Medicines and Medical Technolou, National Institute for Public Health and the Environment, PO. Box I , 3720 BA Bilthoven, The Netherlands (email: [email protected]).
'The participants freely expressed their own views in the workshops, and these d o not necessarily represent the official views of their regulatory authorities. companies, institutions, or organizations.
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International Workshop on Qualification and Control of Impurities* During the DlA International Workshop "lmpurities and Degradation Products-Biological Qualification,Process Capability, and Analytical Control," the EU Committeefor Human Medicinal Products draft guideline on genotoxic impurities was presented. About halfof the attendees expressed their supportfor the use of the threshold of toxicological concern concept as a pragmatic solution. The Food and Drug Administration guidance is under development. The process of qualification of impurities starts with identification. For genotoxic impurities, identification should start with an evaluation of the starting materials and the routes of synthesis to compile a list of impurities that can reasonably be expected to be present in the drug substance. Among this list, the search for alerting structuresand classification of impur
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