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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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A Proposal for a Comprehensive Quality Overall Summary

ISPE

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. For purpose of illustration used throughout this article, labels have been assigned to each CQA.

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

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. 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 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.