Green pharmacy in pharmaceutical processes

Abstract

The application of green pharmaceutical practices during pharmaceutical processes strive to minimise the environmental impact of the pharmaceutical industry. The study aims to evaluate the application of green pharmaceutical practices within the local pharmaceutical manufacturing industry and to develop a tool to assess the greenness of an API manufacturing process. A set of questions were developed and validated by a panel of experts and applied during structured interviews with stakeholders to discuss the use of green pharmaceutical practices, challenges and barriers in implementation. Data collected was analysed thematically. Criteria to be included within the tool were identified through a literature review. The developed tool to quantify the greenness of a process was validated via a focus group consisting of four members having experience within the active pharmaceutical ingredient manufacturing industry. A pilot study was conducting utilising green and conventional pathways found in literature as well as using a shelved synthesis pathway in collaboration with a manufacturing site. Seven out of the 16 companies which satisfied the inclusion criteria agreed to participate in the study. The API manufacturing site was noted to implement wastewater treatment systems (WWTS), green solvents, solvent recovery, one pot synthesis and environmental assessment methods. Finished dosage form manufacturing sites implemented environmental assessment methods (n=2), renewable energy (n=2), paperless approach (n=3) and WWTS (n=1). Barriers and challenges in implementing green practices included financing (n=4) and regulatory aspects (n=3). Criteria identified for inclusion within the greenness assessment tool included raw materials, catalyst, solvent type and amount, percentage yield, atom economy, cleaning steps and solvent classifications and the waste generated. These criteria all have an individual score which in total give an indication of the greenness of a process. The study shows that company size has an influence on the ability to apply, fund and incentivise green practices with large and medium sized enterprises being more willing. A factor noted that impacts application of more sustainable methods was whether processes were developed locally on site. Validation of the scorecard by comparing a green and conventional synthesis pathway confirmed the ability to evaluate the greenness of a process.