CFR section
21 CFR 111.123(a)(8): 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(a)(8) |
|---|---|
| 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) | (8) Approving and releasing, or rejecting, each finished batch for distribution, including any reprocessed finished batch. |
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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.