CFR section
21 CFR 111.210(h)(3): What must the master manufacturing record include?
PART 111-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS · Subpart H-Production and Process Control System: Requirements for the Master Manufacturing Record
Key facts
| Citation | 21 CFR 111.210(h)(3) |
|---|---|
| Section | What must the master manufacturing record include? |
| Part | PART 111-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS |
| Subpart | Subpart H-Production and Process Control System: Requirements for the Master Manufacturing Record |
| Subchapter | 21 CFR B Food |
| Product types cited | Food/Cosmetics |
| Regulation text (excerpt) | (3) Specific actions necessary to perform and verify points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record. (i) Such specific actions must include verifying the weight or measure of any component and verifying the addition of any component; and (ii) For manual operations, such specific actions must include: (A) One… |
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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.