GroundRules
21 CFR 111.255: What is the requirement to establish a batch production record?
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION
- 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
(a) You must prepare a batch production record every time you manufacture a batch of a dietary supplement;
(b) Your batch production record must include complete information relating to the production and control of each batch;
(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
(d) You must make and keep batch production records in accordance with subpart P of this part.
Collected 2026-08-27T02:24:47Z. Source file · JSON