FDA 21 CFR 211: cGMP for Finished Pharmaceuticals
$0.00
FDA federal regulation for the manufacturing of finished pharmaceutical drugﾠ products.ﾠ
The current good manufacturing practice regulations in 21 CFR 211 also apply to drug products, as describe in 21 CFR 600 through 680 (e.g., biological products, blood products) and human cells, tissues, and cellular and tissue-based products (HCT/Ps) and that are drugs, per 21 CFR 1271
21 CFR 211 sections most frequently applied to software include:
- 68: ﾠ Automatic, mechanical, and electronic equipment
- 160: Laboratory controls, general requirements
- 180-198: Records and reports
| Issuing Body | FDA Regulations |
|---|
You may also like…
-
FDA 21 CFR 1271: Human Cells, Tissues, and Cellular and Tissue-based Products, 4/12
This CFR part creates a unified registration and listing system for establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/P’s).
$0.00 Add to cart -
FDA 21 CFR 210: cGMP in Manufacturing, Processing, Packing, or Holding of Drugs
21 CFR Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs provides definitions for terms used in 21 CFR Part 211, 600, 606, 1271, and others.
$0.00 Add to cart -
FDA 21 CFR 600: Biological Products: General
21 CFR 600 applies to the manufacture, inspection, and adverse event reporting for any virus, therapeutic serum, toxin, antitoxin, or analogous products.
$0.00 Add to cart -
FDA 21 CFR 606: cGMP for Blood and Blood Components
21 CFR 606 specifies current Good Manufacturing Practices for blood and blood products.
$0.00 Add to cart
