Calculating the Risk of Batch Failure in the Manufacture of Drug Products

Abstract

A statistical tool has been developed to estimate the risk of batch failure in commercial production from the results of the development scale-up campaigns. This tool serves to indicate the robustness of the manufacturing procedure and its ability to meet the specifications set. Other uses include assistance in the resetting of specifications in the light of actual scale-up batch manufacturing experience and assessing the impact of changes in specifications proposed by the registration authorities. A template is given that simplifies the calculations required.