Active Pharmaceutical Ingredients (APIs) can be present in the environment, primarily as a result of patient use. Manufacturing of APIs and medicinal products can also result in releases of APIs, however, these have historically been considered to be minor in terms of global load [1]. Whilst there is little empirical evidence to confirm the global contribution of manufacturing discharges in surface waters, at a local level manufacturing discharges could contribute more to the overall load of API and this may be particularly evident on a temporal basis [2]. Importantly, these discharges from manufacturing are within the control of the pharmaceutical industry and as such industry has been working for many years to understand and manage the discharge of APIs to protect the environment.

The Pharmaceutical Supply Chain Initiative (PSCI) is a group of pharmaceutical and healthcare companies who share a vision of better social, health, safety and environmental outcomes in the supply chain. As a part of this aim PSCI member companies have prepared case studies demonstrating the management of API discharges. This presentation will share a summary of the approach utilised by industry to assess these discharges along with a small number of these case studies to highlight the work being done at manufacturing sites to improve and reduce the risk posed from API releases from manufacturing sites. Discussion will also summarise potential uncertainties in such assessments and ongoing industry activities to improve assessment and management approaches.