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GMP Publications - Code of Federal Regulation Handbooks by the FDA

Parts 11, 606 and 1271 - Blood, Cell & Tissue with Annex 14

11.606.1271.Anx14

Blood, Cell and Tissue GMPs

  • 21 CFR Part 11 - Electronic Records; Electronic Signatures with Scope & Application
  • 21 CFR Part 606 - Current Good Manufacturing Practice for Blood and Blood Components
  • 21 CFR Part 1271 - Human Cells, Tissues, Cellular & Tissue Based Products
  • EU Annex 14 - Manufacture of Medicinal Products Derived from Human Blood or Plasma
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