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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

The Common Technical Document (CTD) for the Registration of Pharmaceuticals For Human Use: Quality—M4Q guidance covers the minimum requirements for submission of raw materials; however, certain regions have additional requirements. The absence of any of the listed documentation should be scientifically justified.

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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. An energy modeling system such as the 8760-energy model simulates, hour by hour, the proposed energy usage over a 12-month period. link] 29 US Department of Energy.