9.0 - Batch Production Record 211.89 examination or the result of

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

or break under compression during storage or transport

Such reviews should normally be conducted and documented annually

There shall be written procedures describing in sufficient detail the receipt

9.0 - Batch Production Record 211.89 examination or the result ofYou 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