CFR section
21 CFR 111.260(k): What must the batch record include?
PART 111-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS · Subpart I-Production and Process Control System: Requirements for the Batch Production Record
Key facts
| Citation | 21 CFR 111.260(k) |
|---|---|
| Section | What must the batch record include? |
| Part | PART 111-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS |
| Subpart | Subpart I-Production and Process Control System: Requirements for the Batch Production Record |
| Subchapter | 21 CFR B Food |
| Product types cited | Food/Cosmetics |
| Regulation text (excerpt) | (k) Documentation, at the time of performance, of packaging and labeling operations, including: (1) The unique identifier that you assigned to packaging and labels used, the quantity of the packaging and labels used, and, when label reconciliation is required, reconciliation of any discrepancies between issuance and use of labels; (2) An actual or representative label, or a cross-reference to the physical location of the actual or representative label specified in the master manufacturing… |
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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.