The tectonic plates on which pharmaceutical quality regulation rests are shifting, and it is clear that the landscape will not be the same when they settle back down.
There is a striking alignment between regulators and industry on what the forces at work are and how they need to be dealt with. At issue is how to modify the existing regulatory paradigm so that it better empowers science and technology to address the quality, manufacturing, and availability problems facing regulators and industry internationally, which have significant patient consequences.
The December Monthly Update continues to explore some of the transformative initiatives that are underway to bring the vision into practice.
Attacking the problem at its root at the international level is the ICH Q12 effort. Under examination are: ● the obstacles to innovation and continual improvement across the entire product lifecycle, and ● how the relationship between the CMC review process and the way quality systems are regulated post approval needs to shift to remove these obstacles.
IPQ’s coverage includes insights from Q12 industry rapporteur Moheb Nasr on the lifecycle issues that the Q12 working group is addressing and how they play out in the context of analytics, in particular.
The US FDA, meanwhile, is making structural changes in its operations at the field and center levels – and in how they align with each other – to better support the evolving quality principles in practice.
IPQ takes a look at the field operations impact from the vantage point of both ORA management and the boots on the ground. Also reviewed is what the Center for Veterinary Medicine is doing to keep pace with CDER in exploring the new regulatory possibilities.
Also in the issue are over two dozen briefs on other key developments during December in the global quality regulatory arena, along with a compilation of the drug recalls and GMP warning letters posted by FDA during the month.
To access the Monthly Update, subscribers please, click here.