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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. 24 September 2019. Wiley (2019).

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

Published November 2019. link] This novel approach to Module 2 uses a structure that shows how enhanced process knowledge, product understanding, and risk assessments are linked to the control strategy. For purpose of illustration used throughout this article, labels have been assigned to each CQA.

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article thumbnail

A Proposal for a Comprehensive Quality Overall Summary

ISPE

Published November 2019. link] This novel approach to Module 2 uses a structure that shows how enhanced process knowledge, product understanding, and risk assessments are linked to the control strategy. For purpose of illustration used throughout this article, labels have been assigned to each CQA.

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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.