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see ICH Q2(R2)
or break under compression during storage or transport
Drug products that have been subjected to improper storage conditions shall not be salvaged
Quality control personnel must review and approve these decisions and approve the findings and follow-up action of any investigation performed
There shall be written procedures describing in sufficient detail the receipt
9.0 - Batch Production Record 211.89 see ICH Q2(R2)You 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
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