Conveying a convincing control strategy plays a central role in the approvability of the CMC portion of applications. The first story in the Monthly Update for June looks at the control strategy assessment from the FDA CMC reviewer perspective – why understanding it is important, and what sponsors can do to give reviewers what they need to make an approval recommendation. At issue is the challenge for applicants in having to deconstruct their control strategy stories to fit the CTD format, and the challenge for reviewers in reconstructing them. The advice of a key OPQ official on how to make the process go smoother is worth garnering.
The second story explores the role that new excipients can play in empowering drug delivery technology. IPQ focuses on a discussion by MannKind at the June AAPS National Biotech Conference of the development of its inhaled insulin product Afrezza and how the excipient the firm developed was married with insulin and a simple breath-powered drug powder delivery device to make the product viable. The formulation/device technology has promise for other APIs as well. There are a lot of dimensions and implications to MannKind’s experience.
ICH is using the Q&A format to get at some of the more challenging issues that have arisen in the implementation of its two API quality guidelines Q7 (GMPs) and Q11 (CMC development and submission). The third story in the June Monthly Update provides insights from members of the two implementation working groups on the motivations for the Q&As, their focal points and goals.
The Q7 Q&A, which cleared the ICH steering committee at its meeting in Japan in June, takes on 55 different issues spread across the 20 sections of the guideline. The Q&A on the 15 year old guideline grew out of the continuing problems that agencies are seeing in API production, the increasing complexity of the international pharma supply chains, and the recurrent issues and questions that have surfaced between API manufacturers, pharma users and regulators.
The Q11 Q&A project, on the other hand, is just getting underway and will, by contrast, only focus on the section of the guideline that has been most problematic – namely, starting materials. Starting material decisions have important implications in assessing both pre- and post-approval quality submissions, and for GMPs, process validation, and inspections. As such, the stakes are high for both industry and regulators in getting clarity around the expectations for selecting and justifying them, as our story explains.
Included in the issue are “Updates in Brief” on recent developments in the CMC/GMP global arena with links to the referenced documents and to our related in-depth analysis. Also included are the recalls and warning letters listed by FDA during April and May.
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