The progress that industry and regulators are making in implementing the ICH Q8-10/QbD-based regulatory paradigm and where further work needs to be done is the focus of a series of four stories included in the IPQ June “Monthly Update.”
The first of the series reports on the growing emphasis the control strategy is getting among FDA and EU regulators as the nexus for QbD advancement. The story provides insights from US and European CMC management on what the remaining challenges are in shifting to the QbD review paradigm and the role the control strategy needs to play in helping address them.
The importance of the control strategy to the paradigm shift has been drawing attention at the ICH level as well. A new “Points to Consider” has just been released to help flesh out the control strategy development and submission expectations and clarify some of the more pressing issues and questions.
Meanwhile the associations ISPE and PDA have been pulling the expertise of their membership together to create practical and technical guidance on how to put the new ICH QbD, risk management and quality principles into practice. Our third story analyzes the relationship of the ISPE Product Quality Lifecycle Implementation (PQLI) and PDA Paradigm Change in Manufacturing Operations (PCMO) initiatives, the substantial fruit they are beginning to bear and the upcoming contributions they are targeting.
The fourth in the series highlights the current take by one of the key industry players in ICH, John Berridge, on why QbD is a critical tool in navigating the complex manufacturing and supply chain shoals through which pharma is now moving. Berridge is particularly insightful on how QbD creates the flexibility needed to adjust the scale up, launch and production shifts to market demand.
Another focal point in the June Update is the hard look the role of the Qualified Person is getting in the evolving European quality regulatory system with the EU move underway to revise its GMP Annex 16 on QP batch release.
The EMA’s GMP/GDP Inspector’s Working Group (IWG) is working on a concept paper for revising Annex 16 with the aim of better defining and harmonizing the role of the QP across the EU member states. IPQ highlights a discussion of the drivers for the annex revision process and its goals at the PDA/EMA Conference in May by the IWG project lead, Finland’s Anne Junttonen.
A companion story focuses on the early industry/regulator dialogue on the QP issues that need to be addressed, with insights from key European regulators and other stakeholders into how the current situation evolved and where adjustments can and should be made in the context of a more quality systems-oriented regulatory framework.
IPQ’s US coverage for June includes the insights FDA’s drug compliance office is gaining as it takes a closer look at how well manufacturers are applying the Part 11 principles to their computer systems. IPQ reviews what agency investigators are looking for and the misunderstandings and problems they are finding. At issue are the relationships with vendors, what validation entails, and the dictates of the predicate GMPs on which Part 11 is based.
Also reviewed in this issue is the latest in a series of FDA warning letters addressing lab data integrity – the second to an Indian firm this year where environmental monitoring data was at issue.
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