CFR section
21 CFR 211.46(b): Ventilation, air filtration, air heating and cooling
PART 211-CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS · Subpart C-Buildings and Facilities
Key facts
| Citation | 21 CFR 211.46(b) |
|---|---|
| Section | Ventilation, air filtration, air heating and cooling |
| Part | PART 211-CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS |
| Subpart | Subpart C-Buildings and Facilities |
| Subchapter | 21 CFR C Drugs General |
| Product types cited | Biologics, Devices, Drugs, Food/Cosmetics, General, Other_Regulations |
| Regulation text (excerpt) | (b) Equipment for adequate control over air pressure, micro-organisms, dust, humidity, and temperature shall be provided when appropriate for the manufacture, processing, packing, or holding of a drug product. |
At a glance
- 100–999 Inspections citing this section
- 10–99 Warning letters citing this section
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About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.