Good chemical manufacturing process criteria

A tenfold increase in R&D expenditures has been experienced by research-based pharmaceutical companies over the past 25 years. It is incumbent upon these producers to find ways to reduce manufacturing costs. One approach that uses innovative developments leads to targeted product structures and workflow has been assembled by contributors from Boehringer Ingelheim Pharma & Pharmaceuticals. A series of eight criteria: material cost, process efficiency, yield, volume-time-output (VTO), environmental factor (E factor/process mass intensity), quality service level, process excellence index, and modified EcoScale were found to greatly support cost-saving efforts. Many of these components have received extensive attention in the literature. The individual contributions of the criteria to the chemical process development offer a significant aid to query each stage of synthetic development for improved good manufacturing practice. For instance synthetic planning in a linear format can be improved through considerations of convergent synthetic approaches to the target chemical. A highly useful EcoScale template accompanies the article to permit an understanding of the analysis at a glance. A weighting factor scheme for the use of the eight criteria for a good chemical process is offered to facilitate the overall analysis. Criteria weighting is expected to change for different process optimization objectives and economic priorities. Org Process Res Dev 2012, 16, 1697–1706.