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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. This article summarizes an alternate and more functional way to format the QOS presented in Module 2.3.

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. This article summarizes an alternate and more functional way to format the QOS presented in Module 2.3.

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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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Regulatory Landscape for Raw Materials: CMC Considerations

ISPE

In this article, the term “raw material” refers to a material used in the manufacturing and packaging of a drug substance (DS) or a drug product (DP). This article highlights the regulatory expectations of raw materials, the challenges of postapproval changes. Published November 2019. and the impact on supply resiliency.