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THE QUALITY PARADIGM FOR DRUG EXCIPIENTS

This article was originally published in The Gold Sheet

Executive Summary

...needs to be refocused onto their composition and away from the impurities orientation in the API arena, the International Pharmaceutical Excipients Council is urging. Clearer definition of excipient components, mixtures and additives is viewed as critical to more effective communication between suppliers, drug manufacturers and regulators, and IPEC is working on a guideline to help build the foundation for compendial realignment and harmonization accordingly. Meanwhile, dosage manufacturers are tightening their excipient control systems and looking at new analytical technologies to meet the quality by design challenge.

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