9.0 - Batch Production Record 211.89 or break under compression during

or break under compression during storage or transport

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

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

Such reviews should normally be conducted and documented annually

see ICH Q2(R2)

9.0 - Batch Production Record 211.89 or break under compression duringYou 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