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A Proposal for a Comprehensive Quality Overall Summary

ISPE

9 Among other things, the M4Q(R2) EWG is working toward “organizing product and manufacturing information in a suitable format for easy access, analysis, and knowledge management.” Currently, it takes time and/or communications (e.g., information requests) to fully understand the quality data and its significance in an application.”

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

9 Among other things, the M4Q(R2) EWG is working toward “organizing product and manufacturing information in a suitable format for easy access, analysis, and knowledge management.” Currently, it takes time and/or communications (e.g., information requests) to fully understand the quality data and its significance in an application.”

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Regulatory Landscape for Raw Materials: CMC Considerations

ISPE

The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines contain information regarding regulatory requirements for raw materials. The name of each material, where it is used in the process, and information on the quality and control should be provided.

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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). linear) design process is central to successfully attaining such comprehensive sustainability goals and project needs (see Figure 1). 7 An integrative (vs. 7 An integrative (vs. Accessed 3 December 2022.