21 CFR §111.255

1. (a)You must prepare a batch production record every time you manufacture a batch of a dietary supplement;
2. (b)Your batch production record must include complete information relating to the production and control of each batch;
3. (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
4. (d)You must make and keep batch production records in accordance with subpart P of this part.