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A Proposal for a Comprehensive Quality Overall Summary

ISPE

Published 12 September 2002. 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. link] 10 a b c US Food and Drug Administration. “A link] 11 Beierle, J., Cauchon, T.

article thumbnail

A Proposal for a Comprehensive Quality Overall Summary

ISPE

Published 12 September 2002. 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. link] 10 a b c US Food and Drug Administration. “A link] 11 Beierle, J., Cauchon, T.

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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. Published 2002. This is followed by DP manufacturing, where the DS is formulated with excipients.