CFR section
21 CFR 111.365(h): What precautions must you take to prevent contamination?
PART 111-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS · Subpart K-Production and Process Control System: Requirements for Manufacturing Operations
Key facts
| Citation | 21 CFR 111.365(h) |
|---|---|
| Section | What precautions must you take to prevent contamination? |
| Part | PART 111-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS |
| Subpart | Subpart K-Production and Process Control System: Requirements for Manufacturing Operations |
| Subchapter | 21 CFR B Food |
| Product types cited | Drugs, Food/Cosmetics |
| Regulation text (excerpt) | (h) Performing mechanical manufacturing steps (such as cutting, sorting, inspecting, shredding, drying, grinding, blending, and sifting) by any effective means to protect the dietary supplements against contamination, by, for example: (1) Cleaning and sanitizing contact surfaces; (2) Using temperature controls; and (3) Using time controls. |
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.