A quality control method enhancement concept-Continual improvement of regulatory approved QC methods.

Dennis Åsberg,Mikael Nilsson, Susanne Olsson,Jörgen Samuelsson,Olof Svensson,Silke Klick, Julie Ennis,Paul Butterworth, Denise Watt, Stavroula Iliadou, Angelica Karlsson, Joanne T Walker, Kate Arnot, Norb Ealer, Kerstin Hernqvist,Karin Svensson, Ali Grinell,Per-Ola Quist,Anders Karlsson,Torgny Fornstedt

Journal of Pharmaceutical and Biomedical Analysis（2016）

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摘要

•A new concept for QC-method development in drug manufacturing is presented.•The concept proposes less interaction with regulators for minor adjustments.•The concept is exemplified with the switch from HPLC to UHPLC.•The approach was found to be practically feasible.

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关键词

Method enhancement concept,Quality by design,Continual improvement,HPLC,Method transfer

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