FDA 21 CFR 210: cGMP in Manufacturing, Processing, Packing, or Holding of Drugs
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21 CFR Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs provides definitions for terms used in
- 21 CFR 1271, cGMP for human cells, tissues, and cellular and tissue-based products
- 21 CFR 211, cGMP for finished pharmaceuticals
- 21 CFR 225, cGMP for medicated feeds
- 21 CFR 226, cGMP for type A medicated articles
- 21 CFR 600, biological products
- 21 CFR 606, cGMP for blood and blood components
- 21 CFR 610, biological product standards
- other parts from 21 CFR 600 – 21 CFR 680
| Issuing Body | FDA Regulations |
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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).
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FDA 21 CFR 211: cGMP for Finished Pharmaceuticals
FDA federal regulation for the manufacturing of finished pharmaceutical drug products.ﾠ
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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.
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FDA 21 CFR 606: cGMP for Blood and Blood Components
21 CFR 606 specifies current Good Manufacturing Practices for blood and blood products.
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