AstraZeneca's SHE (Safety, Health, Environment) Triggers model has been used to drive environmental improvement in the process development of Active Pharmaceutical Ingredients for a number of years. Changing industry pressures, driving new internal ways of working, led to a review of SHE Triggers to generate a fit for purpose, flexible methodology for modern pharmaceutical development.

Process development milestones are used to trigger environmental assessment tasks, with focus shifting from prevent, to minimise and render harmless through the development cycle. The methodology is driven from an early stage by a risk-based approach to the prioritisation of improvement actions, based on a simple product tonnage/material hazard model. The output is an environmental risk profile that can be easily interpreted and acted upon by process chemists and engineers, both within the company and at external contract manufacturers. Risk profiles additionally enable better resource allocation across projects, to ensure effort is focussed on the process steps with the greatest environmental impact. The risk profile is easily updated to allow re-appraisal of the process throughout the development cycle to deliver environmentally sound commercial manufacturing processes.