CFR section
21 CFR 111.255(b): 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(b) |
|---|---|
| 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, General, Other_Regulations, Veterinary |
| Regulation text (excerpt) | (b) Your batch production record must include complete information relating to the production and control of each 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.