As quality by design goes commercial drug manufacturers struggle to translate concepts that made sense in the lab into processes that work in the manufacturing plant, they tell ISPE Washington conference PQLI session. The focus turns to training and communications challenges. FDA reviewers coach investigators on what to look for in a QbD inspection. Post-CMC pilot QbD applications roll in the door at FDA. The agency shares advice on crafting these submissions: Don't forget about 'residual risk.' Remember to maintain your design spaces. Keep in mind how the criticality determination process is evolving. Increasingly, design spaces are defined by models, but those models pose challenges to manufacturing equipment operators. The same goes for 'operationalizing' new QbD control strategies. The key: Get operations personnel involved.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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