CFR section
21 CFR 600.11(a): Physical establishment, equipment, animals, and care
PART 600-BIOLOGICAL PRODUCTS: GENERAL · Subpart B-Establishment Standards
Key facts
| Citation | 21 CFR 600.11(a) |
|---|---|
| Section | Physical establishment, equipment, animals, and care |
| Part | PART 600-BIOLOGICAL PRODUCTS: GENERAL |
| Subpart | Subpart B-Establishment Standards |
| Subchapter | 21 CFR F Biologics |
| Product types cited | Biologics, Drugs, Food/Cosmetics, Other_Regulations |
| Regulation text (excerpt) | (a) Work areas. All rooms and work areas where products are manufactured or stored shall be kept orderly, clean, and free of dirt, dust, vermin and objects not required for manufacturing. Precautions shall be taken to avoid clogging and back-siphonage of drainage systems. Precautions shall be taken to exclude extraneous infectious agents from manufacturing areas. Work rooms shall be well lighted and ventilated. The ventilation system shall be arranged so as to prevent the dissemination of… |
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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.