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.