IPEC QbD Excipient Sampling Guide

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] In order to facilitate communication between excipient and drug makers in the development of successful new drug appli- cations utilizing QbD principles, IPEC-Americas published its Quality by Design Sampling Guide in early May. The guide is intended, among other things, to help drug makers develop “more robust processes and products in the context of the excipient manufacturer’s process capability” and “delineate user and excipient supplier roles and responsibilities.”
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