CFR section
21 CFR 111.123(b)(4): What quality control operations are required for the master manufacturing record, the batch production record, and manufacturing operations?
PART 111-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS · Subpart F-Production and Process Control System: Requirements for Quality Control
Key facts
| Citation | 21 CFR 111.123(b)(4) |
|---|---|
| Section | What quality control operations are required for the master manufacturing record, the batch production record, and manufacturing operations? |
| Part | PART 111-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS |
| Subpart | Subpart F-Production and Process Control System: Requirements for Quality Control |
| Subchapter | 21 CFR B Food |
| Product types cited | Drugs, Food/Cosmetics |
| Regulation text (excerpt) | (4) Any product received from a supplier for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier) for which sufficient assurance is not provided to adequately identify the product and to determine that the product is consistent with your purchase order. |
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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.