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A Proposal for a Comprehensive Quality Overall Summary

ISPE

One possible solution raised was a Module 2 that integrates the product development story, links the product attributes to the drug product (DP) and drug substance (DS) manufacturing processes to demonstrate a holistic drug product control strategy, and demonstrates how the control strategy supports the TPP.

article thumbnail

A Proposal for a Comprehensive Quality Overall Summary

ISPE

One possible solution raised was a Module 2 that integrates the product development story, links the product attributes to the drug product (DP) and drug substance (DS) manufacturing processes to demonstrate a holistic drug product control strategy, and demonstrates how the control strategy supports the TPP.

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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). Green Building Council, 2014. query=environment Labeling and Organization There are various ways to group the many types of environmental sustainability challenges and goals. 30 July 2014.