9.0 - Batch Production Record 211.89 Such reviews should normally be

Such reviews should normally be conducted and documented annually

examination or the result of any monitoring fails to meet an established specification

see ICH Q2(R2)

or break under compression during storage or transport

and closures shall be withheld from use in quarantine until the lot has been sampled

9.0 - Batch Production Record 211.89 Such reviews should normally beYou must prepare a batch production record every time you manufacture a batch of a dietary supplement including complete information relating to the production and control of each batch. Your batch production record must accurately follow each step of the appropriate master manufacturing record