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Purpose <p>Analytical methods of pharmaceutical quality control (QC) are typically selected for regulatory compliance and analytical performance, while sustainability and operational feasibility are often secondary. This case study aimed to demonstrate how combining greenness and whiteness metrics can support method-related decisions in QC under batch practice.</p> Methods <p>Compendial non-aqueous potentiometric titrations (PT) for aromatic amino acids used as raw materials were compared with alternatives spectrofluorimetric methods (SFM) developed for assays. The Advanced National Environmental Methods Index (advanced NEMI) was applied during development as an early screening tool, followed by the Analytical Eco-Scale and Green Analytical Procedure Index (GAPI), and Analytical GREEnness metric (AGREE) to quantify and localize environmental burdens under finalized conditions. Finally, White Analytical Chemistry (WAC) was employed to integrate analytical performance, environmental impact, and implementation practicality.</p> Results <p>Across these tools, PT was penalized by corrosive non-aqueous chemistry and higher hazardous reagent and waste demands, implying greater safety controls and waste-handling effort at scale. Triangulation converged on the same decision signal: SFM remained fit for release testing while reducing hazardous touchpoints and simplifying waste logistics, yielding superior greenness indicators (Eco-Scale: 93 vs. 76; AGREE: 0.61 vs. 0.34) and a higher WAC score (81.3 vs. 65.5).</p> Conclusion <p>Overall, the metric set shifted the basis from “analytically compliant” to “fit for deployment,” framed by a Six Sigma improvement logic (Define–Measure–Analyze–Improve–Control), thereby strengthening sustainability-informed analytical development and change-control decisions in industrial QC.</p>

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Integrating Sustainability Metrics Into Analytical Decision-Making in Biopharmaceutical Quality Control: An Industrial Case Study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年6月18日

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  • Thallis Martins Souza

摘要

Purpose

Analytical methods of pharmaceutical quality control (QC) are typically selected for regulatory compliance and analytical performance, while sustainability and operational feasibility are often secondary. This case study aimed to demonstrate how combining greenness and whiteness metrics can support method-related decisions in QC under batch practice.

Methods

Compendial non-aqueous potentiometric titrations (PT) for aromatic amino acids used as raw materials were compared with alternatives spectrofluorimetric methods (SFM) developed for assays. The Advanced National Environmental Methods Index (advanced NEMI) was applied during development as an early screening tool, followed by the Analytical Eco-Scale and Green Analytical Procedure Index (GAPI), and Analytical GREEnness metric (AGREE) to quantify and localize environmental burdens under finalized conditions. Finally, White Analytical Chemistry (WAC) was employed to integrate analytical performance, environmental impact, and implementation practicality.

Results

Across these tools, PT was penalized by corrosive non-aqueous chemistry and higher hazardous reagent and waste demands, implying greater safety controls and waste-handling effort at scale. Triangulation converged on the same decision signal: SFM remained fit for release testing while reducing hazardous touchpoints and simplifying waste logistics, yielding superior greenness indicators (Eco-Scale: 93 vs. 76; AGREE: 0.61 vs. 0.34) and a higher WAC score (81.3 vs. 65.5).

Conclusion

Overall, the metric set shifted the basis from “analytically compliant” to “fit for deployment,” framed by a Six Sigma improvement logic (Define–Measure–Analyze–Improve–Control), thereby strengthening sustainability-informed analytical development and change-control decisions in industrial QC.