CFR section
21 CFR 111.260(c): 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(c) |
|---|---|
| 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 | Drugs, Food/Cosmetics |
| Regulation text (excerpt) | (c) The date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch, or a cross-reference to records, such as individual equipment logs, where this information is retained; |
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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.