CFR section
21 CFR 111.260(j): 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(j) |
|---|---|
| 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, General, Other_Regulations |
| Regulation text (excerpt) | (j) Documentation, at the time of performance, of the manufacture of the batch, including: (1) The date on which each step of the master manufacturing record was performed; and (2) The initials of the persons performing each step, including: (i) The initials of the person responsible for weighing or measuring each component used in the batch; (ii) The initials of the person responsible for verifying the weight or measure of each component used in the batch; (iii) The initials of the person… |
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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.