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Environmental Sustainability in Biopharmaceutical Facility Design

ISPE

linear) design process is central to successfully attaining such comprehensive sustainability goals and project needs (see Figure 1). query=environment Labeling and Organization There are various ways to group the many types of environmental sustainability challenges and goals. 14–25 (November–December 2021). 25 February 2021.

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

Published 15 November 2021. For purpose of illustration used throughout this article, labels have been assigned to each CQA. The authors propose using Module 2.3 3 1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.”

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article thumbnail

A Proposal for a Comprehensive Quality Overall Summary

ISPE

Published 15 November 2021. For purpose of illustration used throughout this article, labels have been assigned to each CQA. The authors propose using Module 2.3 3 1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.”

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Regulatory Landscape for Raw Materials: CMC Considerations

ISPE

In the long term, a collaboration between regulators and industry stakeholders to develop and implement harmonized guidelines for raw materials would help address flexibility challenges, prevent delays in implementing process improvements, and ensure that both regulator and industry resources are devoted to the most critical issues.