Transcription of EU GMP Requirements
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EU GMP Requirements
Trade & Industry Inspection Agency ofLower Saxony / Germany, Hannover officeBernd BoedeckerGMP Inspectorate of Hannover / GermanyEU GMP Requirements - investigational medicinal Products -at Turkish Ministry of HealthAnkara, 20-21 Oct 2009 Trade & Industry Inspection Agency ofLower Saxony / Germany, Hannover officeTMH, Ankara, 20-21 Oct 2009 Bernd Boedecker2contact dataBernd BoedeckerStaatliches Gewerbeaufsichtsamt HannoverDezernat 74 (GMP Inspectorate)Am Listholze 74D-30177 Hannoverphone: +49 (0)511 / 9096-464fax : +49 (0)511 / & Industry Inspection Agency ofLower Saxony / Germany, Hannover officeTMH, Ankara, 20-21 Oct 2009 Bernd Boedecker3 Contents covered Legislationrelated to investigational medicinal Products (IMPs) IMP terminology Focal points of inspectionsat IMP manufacturing sites Revision of Annex 13 current status GMP
IMPD = Investigational Medicinal Product Dossier (part of CTA) . PSF = Product Specification File (references for manufact.) . Comparator = reference product (active or placebo) . Randomisation = assigning trial subjects to treatment or control groups by using an element of chance . Blinding = keeping parties unaware of treatment assignment. EMEA
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