CFR section
21 CFR 111.255(c): What is the requirement to establish a batch production record?
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 111.255(c) |
|---|---|
| Section | What is the requirement to establish a batch production record? |
| 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, Other_Regulations |
| Regulation text (excerpt) | (c) Your batch production record must accurately follow the appropriate master manufacturing record and you must perform each step in the production of the batch; and |
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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.