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Batch manufacturing and Handle records shall be ready for every batch of drug merchandise produced and shall contain complete facts regarding the generation and Charge of Every single batch. These data shall involve:Such calculations shall possibly be done by 1 man or woman and independently verified by a next man or woman, or, if the generate is c

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For example, although the CPG isn't going to specifically mention concurrent validation for an API Briefly source, the Company would think about the use of concurrent validation when it is necessary to address a real short-provide circumstance, and In case the concurrent validation review conforms into the situations determined while in the CPG (se

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