Code of Federal Regulations Title 21. Food and Drugs § 21.111.255 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.