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

see ICH Q2(R2)

Quality control personnel must review and approve these decisions and approve the findings and follow-up action of any investigation performed

or break under compression during storage or transport

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