US GMPs applicable to Combination products

Note. Minimum order volume: 30 booklets.
Contact customer service to order→
(appr 2 weeks delivery)

For smaller numbers we recommend the e-book version →

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

Pages: 102
Language: English
Binding: Wire
Dim: 95×155 mm

#1020en