CFR section
21 CFR 211.113(a): Control of microbiological contamination
PART 211-CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS · Subpart F-Production and Process Controls
Key facts
| Citation | 21 CFR 211.113(a) |
|---|---|
| Section | Control of microbiological contamination |
| Part | PART 211-CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS |
| Subpart | Subpart F-Production and Process Controls |
| Subchapter | 21 CFR C Drugs General |
| Product types cited | Biologics, Devices, Drugs, Food/Cosmetics, General, Other_Regulations, Veterinary |
| Regulation text (excerpt) | (a) Appropriate written procedures, designed to prevent objectionable microorganisms in drug products not required to be sterile, shall be established and followed. |
At a glance
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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.