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A Proposal for a Comprehensive Quality Overall Summary

ISPE

This article summarizes an alternate and more functional way to format the QOS presented in Module 2.3. The TPP defines the indication and patient population, describes usage of the product, provides dosage and administration details, explains dosage form and strengths, and lists packaging and storage requirements.

article thumbnail

A Proposal for a Comprehensive Quality Overall Summary

ISPE

This article summarizes an alternate and more functional way to format the QOS presented in Module 2.3. The TPP defines the indication and patient population, describes usage of the product, provides dosage and administration details, explains dosage form and strengths, and lists packaging and storage requirements.

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Environmental Sustainability in Biopharmaceutical Facility Design

ISPE

Sustainability Tools and Design Processes When promoting of an initiative’s environmental sustainability ES, we should include a more comprehensive context that considers planet (natural capital), people (social capital), and profit (economic capital). Table 2: Organization and labeling examples for environmental sustainability issues.

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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). Finally, the DP is packaged in a suitable container to ensure continued quality. This is followed by DP manufacturing, where the DS is formulated with excipients.