Collection of the US GMP/QSR regulations applicable to Combination products in a single handy booklet.
21 CFR Part 4: Regulation of Combination Products
21 CFR Part 11: Electronic Records; Electronic Signatures
21 CFR Part 210: Current Good Manufacturing Practice in Manufacturing, Processing, Packing or Holding of Drugs; General
21 CFR Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals
21 CFR Part 820; Quality System Regulation
Dim: 95×155 mm
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