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.
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
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.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
A new pilot aims to take Brazil closer to ‘digital transformation.’
The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.
In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.
The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.
