| Sumario: | The article focuses on the integration of environmental sustainability strategies and metrics into pharmaceutical manufacturing, providing a comprehensive framework intended for manufacturers, regulators, inspectors, and related stakeholders. It outlines risk-based, measurable, and auditable approaches to incorporate sustainability principles—such as green chemistry, energy and water efficiency, waste minimization, solvent management, and carbon footprint assessment—within good manufacturing practices (GMP) without compromising product quality, patient safety, or regulatory compliance. Key metrics discussed include Process Mass Intensity (PMI), Environmental Factor (E-factor), atom economy, carbon intensity, and Scope 1–3 greenhouse gas emissions, supported by life cycle assessment (LCA) methodologies to evaluate environmental impacts across product lifecycles. The document emphasizes management responsibilities, training, digital technology applications, and regulatory considerations to promote harmonized, practical, and continuous improvement approaches aligned with international standards and the United Nations Sustainable Development Goals.
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