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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. 7 An integrative (vs. Accessed 3 December 2022.

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

For purpose of illustration used throughout this article, labels have been assigned to each CQA. The QTPP describes elements of the product related to quality, safety, and efficacy, as shown in Table 1. Table 1: Linkage among patient consideration, product design, target attributes and CQAs.

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article thumbnail

A Proposal for a Comprehensive Quality Overall Summary

ISPE

For purpose of illustration used throughout this article, labels have been assigned to each CQA. The QTPP describes elements of the product related to quality, safety, and efficacy, as shown in Table 1. Table 1: Linkage among patient consideration, product design, target attributes and CQAs.

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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.