Greta Adorni1, Angelo Carini1, Michela Lomazzi2, Loredana Battipaglia1, Orsola Vecchi1, Margherita Gianferrari1, Davide Borrini1 & Valeria Cavatorta1
1Chiesi Farmaceutici S.p.A, Largo Belloli, Parma, 11/a, 43122, Italy
2TEAM mastery S.r.l. Via G. Ferrari, Como, 14/B, 22100, Italy
Summary
The presence of pharmaceuticals in the environment is a growing global concern1. Chiesi Farmaceutici S.p.A., as a member of the European Federation of Pharmaceutical Industry Association (EFPIA), shares the widespread concern raised by the presence of pharmaceuticals in the environment and embraces the adoption of the Resolution of the European Parliament on the Strategic Approach to Pharmaceuticals in the Environment (PiE). In accordance with its commitment to operate with integrity, in a socially and environmental responsible care, Chiesi applied a tiered approach for the identification of potential environmental risks of active pharmaceutical ingredients (APIs) and related products in order to define an environmental targeted assessment strategy. In this study, all the main potential environmental exposure patterns were investigated, and specific systems to reduce and treat manufacturing discharges were identified. LC-MS analytical methods were developed to monitor and then subsequently estimate a predicted environmental concentration (PEC). As directed by EFPIA guidance2, environmental fate alongside ecotoxicological studies were carried out in order to set the appropriate hazard levels and safe concentrations (PNECs: Predicted No Effect Concentrations). Preliminary monitoring campaigns were planned with the goal of refining the predicted PEC thus providing a realistic and responsible view of potential hazards and risks. The study addressed the characterization of the environmental risk in terms of the quotient PEC/PNEC which for the APIs studied was demonstrated to be below 1. Hence, the manufacturing discharges were assessed to not pose an environmental risk.