Regulatory Landscape for Raw Materials: CMC Considerations
ISPE
AUGUST 30, 2022
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 May 2012. 4 The International Pharmaceutical Excipients Council (IPEC). Published 2008.
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