Environmental sustainability and climate change mitigation measures in pharmaceutical manufacturing: a scoping review of global evidence and regulatory frameworks

Pharmaceutical manufacturing is a material contributor to the environmental footprint of healthcare through energy-intensive processes, solvent-dominated waste streams, and the discharge of active pharmaceutical ingredients and micropollutants to water ecosystems. Despite growing concern regarding the environmental impacts of pharmaceutical manufacturing, environmental sustainability is not a primary objective of conventional good manufacturing practice (GMP) frameworks, and cleaner production principles remain unevenly integrated into pharmaceutical manufacturing regulation and practice. This scoping review, conducted following JBI methodology and reported in accordance with PRISMA-ScR, mapped peer-reviewed and gray literature published from 2000 through July 2025 on environmental sustainability and climate change mitigation in pharmaceutical manufacturing. A protocol was registered with the Open Science Framework ( osf.io/zyfek ). A comprehensive search of MEDLINE, Embase, Global Health, Web of Science, and gray literature sources (WHO IRIS, OECD iLibrary, UN Environment databases, Google Scholar, ProQuest) was executed on 3 July 2025. Two reviewers screened records independently using Covidence (κ = 0.79 title/abstract; κ = 0.84 full-text). From 2,943 screened records, 125 met inclusion criteria. Green chemistry metrics (E-factor, Process Mass Intensity) were the most frequently reported sustainability measure (36% of the 125 records), followed by climate impact assessments (24%) and solvent-related criteria (17%). Industrial-scale operations were the most frequently reported (50%), and non-traditional manufacturing modes (continuous flow, process intensification, hybrid systems) featured in a third of records (33%). Only eight records (6.4%) explicitly referenced WHO GMP, reflecting limited engagement with regulatory organizations within the scholarly literature retrieved rather than necessarily a gap in industry practice. Barriers clustered into economic, regulatory, technical, organizational, and environmental domains. The mapped literature on cleaner production in pharmaceutical manufacturing is dominated by waste- and mass-efficiency metrics, while lifecycle and ecological safety dimensions remain underaddressed. These gaps suggest that integrating explicit environmental provisions into major GMP frameworks—grounded in the full breadth of green chemistry principles and the planetary boundaries framework—warrants further consideration as a means of supporting global harmonization and equitable implementation, particularly for low- and middle-income country manufacturers.