CFR section
21 CFR 211.42(c)(10): Design and construction features
PART 211-CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS · Subpart C-Buildings and Facilities
Key facts
| Citation | 21 CFR 211.42(c)(10) |
|---|---|
| Section | Design and construction features |
| 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 | Devices, Drugs, Food/Cosmetics, General, Other_Regulations |
| Regulation text (excerpt) | (10) Aseptic processing, which includes as appropriate: (i) Floors, walls, and ceilings of smooth, hard surfaces that are easily cleanable; (ii) Temperature and humidity controls; (iii) An air supply filtered through high-efficiency particulate air filters under positive pressure, regardless of whether flow is laminar or nonlaminar; (iv) A system for monitoring environmental conditions; (v) A system for cleaning and disinfecting the room and equipment to produce aseptic conditions; (vi) A system… |
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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.