Release by Exception Project Design Optimization

Abstract

Pharmaceutical companies are trying to improve the adverse effects that technology brings with the change in documentation. Going from a paper record to an electronic record is a new challenge that must be absorbed and implemented as a growth projection. The objective of this study is to implement the Release by Exception, analyzing, and obtaining only the critical steps of the process that must be complied according to regulation requirements. At the same time, this study contemplates improving other areas that guarantee the release of as many batches as possible. In other words, optimize the process to make it more efficient and effective without forgetting critical details. The research question is the following: What improvement strategy can be achieved under the implementation? In this context, the use of the Lean manufacturing principles and DMAIC methodology through the analysis of a representative sample of 30 manufacturing lots provides the way to achieves the objectives. The implementation of Release by Exception with DMAIC method indicates that, under a redistribution of the certified assigned personnel, the determination and justification of the critical steps and the reduction of open exceptions, a single batch of Adalimumab currently takes between 51 to 58 days from manufacture to final approval by Quality department as expected. Key Terms ⎯ DMAIC, Electronic Record, Release by Exception, Quality department.