CFR section
21 CFR 111.20(d): What design and construction requirements apply to your physical plant?
PART 111-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS · Subpart C-Physical Plant and Grounds
Key facts
| Citation | 21 CFR 111.20(d) |
|---|---|
| Section | What design and construction requirements apply to your physical plant? |
| Part | PART 111-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS |
| Subpart | Subpart C-Physical Plant and Grounds |
| Subchapter | 21 CFR B Food |
| Product types cited | Drugs, Food/Cosmetics |
| Regulation text (excerpt) | (d) Be designed and constructed in a manner that prevents contamination of components, dietary supplements, or contact surfaces. (1) The design and construction must include: (i) Floors, walls, and ceilings that can be adequately cleaned and kept clean and in good repair; (ii) Fixtures, ducts, and pipes that do not contaminate components, dietary supplements, or contact surfaces by dripping or other leakage, or condensate; (iii) Adequate ventilation or environmental control equipment such as… |
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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.