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Considerations for a Decentralized Manufacturing Paradigm

ISPE

September 2004. Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice.” September 2004. Aseptic Processing: A Vision of the Future.” Product Focus: Advancing Aseptic Processing.” Journal of Pharmaceutical Sciences 111, no. 3 (2022):593–607. 4 US Food and Drug Administration.

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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.

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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). March 2004. 7 An integrative (vs. link] 28 World Resources Institute and World Business Council for Sustainable Development. The Greenhouse Gas Protocol: A Corporate Accounting and Reporting Standard.”