Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 2 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / 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 / § 111.255 What is the requirement to establish a batch production record?
§ 111.255 What is the requirement to establish a 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.