9.0 - Batch Production Record 211.89 Drug products that have been

Drug products that have been subjected to improper storage conditions shall not be salvaged

including effective and reproducible cleaning processes to control risk of cross-contamination

or break under compression during storage or transport

There shall be written procedures describing in sufficient detail the receipt

Such reviews should normally be conducted and documented annually

9.0 - Batch Production Record 211.89 Drug products that have beenYou 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