The intensive effort of ICH’s Q3D Expert Working Group (EWG) to come up with harmonized expectations for evaluating elemental impurities in pharmaceutical products that will be palatable to the varied stakeholders involved has borne fruit, and a Step 2 draft guideline is now out on the table for public comment. The guideline has wide-ranging relevance across product types, lifecycle phases, and ingredient supply chains.
The Monthly Update for October delves into the issues that the EWG wrestled with in finalizing the Step 2 draft, how the extensive pre-Step 2 vetting process factored in, and the implementation challenges that will need to be faced.
The first of the companion stories focuses on insights from key EWG members on how the drafting decisions were made and why. The second explores some of the implementation concerns and what industry and its ingredient suppliers are doing to better understand and address them.
Also in focus in the October Monthly Update is the release by FDA of a draft guidance covering quality agreements for contract manufacturing arrangements – an area that is very high on the FDA compliance radar screen.
IPQ delves into the guidance and its implications from three vantage points:
● The first story in the series provides insights into its development and intent from the CDER compliance official who lead the drafting process.
● The second story explores the compliance office’s current concerns with tech transfer in contracting arrangements and the role the quality agreement plays in supporting its success. It includes an eye-opening case study with which the compliance office was recently involved that highlights the pitfalls that can surface in contracting relationships when the channels for knowledge transfer are not open.
● The third provides an analysis of the heavy feedback FDA got during the comment phase on the new draft, which speaks to the multidimensional challenges that contracting arrangements present and the compliance breakdowns that have been occurring.
Another area drawing considerable IPQ attention recently is FDA’s efforts to implement the far-reaching provisions of Title VII of FDASIA. The agency has been seeking advice from industry and other stakeholders on how to most effectively move forward on those it has prioritized.
The September Monthly Update provided coverage of the industry feedback on sections 713 and 714 on registration of foreign importers and good importer practices and on section 707, which strengthens FDA’s enforcement clout when inspections are obstructed by being able to designate drugs from the facility involved “adulterated.”
In this issue, IPQ focuses on a third component in the FDASIA toolbox, providing the agency with the ability to detain products if inspection findings raise red flags without having to go through the cumbersome seizure process with the courts. The story includes a review of the comments that came in on the draft rule released by FDA that fleshes out this provision. It also contains interesting revelations from one of FDASIA’s coauthors on how the bill made its way through the current stormy legislative environment in the US en route to passage.
The issue leads off with a story highlighting what CBER management is saying will be its top compliance initiatives and priorities over the next year for the range of biologic products it regulates.
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