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The EU GMPs include Chapters 1-9 EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary
807 - Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
Part 312 Investigational New Drug Application
Includes ICH Q7 (Annex 18/Part II)
Parts 11, 606 and 1271 - Blood Cell & Tissue GMPs DEA The EU GMPs include ChaptersBlood, Cell and Tissue GMPs 21 CFR Part 11 Electronic Records; Electronic Signatures with Scope & Application 21 CFR Part 606 GMPs for Blood and Blood Components 21 CFR Part 1271 Human Cells, Tissues, Cellular & Tissue Based Products Optional EU Annex 14 Manuf. of Medicinal Products Derived from Human Blood or Plasma 21CFR11 606 1271 C 251229
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