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. § 111.260 What must the batch record include? The batch production record must include the following: (a) The batch, lot, or control number: (1) Of the finished batch of dietary supplement; and (2) That you assign in accordance with §111.415(f) for the following: (i) Each lot of packaged and labeled dietary supplement from the finished batch of dietary supplement; (ii) Each lot of dietary supplement, from the finished batch of dietary supplement, that you distribute to another person for packaging or labe
