Speakers representing the FDA and several IPAC-RS working groups dominated day 2 of the 2011 IPAC-RS conference, with presentations and panel discussions on the day’s main topic, “Product Quality.” The day began with the keynote address delivered by Prasad Peri of the FDA’s Office of New Drug Quality Assessment and concluded with the announcement of the poster awards, with two of the top three prizes going to posters from MannKind Corporation.
Dr. Peri’s talk, titled “FDA View on Assessing Quality of Inhaled Products and Links to Efficacy and Safety,” dealt with several testing methodologies covered in more detail in later presentations, in particular the question of using a parametric tolerance interval test (PTIT) for delivered dose uniformity (DDU) testing as opposed to the method laid out in the 1998 draft guidance and the question of full resolution cascade impactor testing versus the abbreviated impactor method (AIM).
In the first case, Peri said, the FDA believes that the PTIT approach is more scientific than the current test and that the elimination of the zero tolerance approach is warranted. In addition, he said the FDA was interested in the exploration of the same type of approach for additional attributes beyond DDU.
In the case of the AIM method, Peri remained non-committal, saying only that the FDA is “open to discussion related to alternative apparatuses” but that issue raised by statisticians still need to be addressed. In response to a question from the floor about what specific issues still need to be dealt with, he repeated his assertion that he was “not saying that that it’s not suitable” but that more study was necessary.
During the morning panel discussion, when challenged about the conservative, risk-averse nature of the FDA compared to the more progressive actions of the European regulators, Dr. Peri responded that “It’s easy to be rash and to take imperfect methods forward” but that doing so could lead to problems for reviewers, reiterating: “It’s better to take it slow and steady.”
After Dr. Peri’s talk, Andy Rignall, representing the IPAC-RS Analytical Methods Working Group; Greg Larner, representing the DDU/PTIT Working Group; Terry Tougas, representing the Cascade Impactor Working Group; and Trevor Riley and David Christopher of the Dissolution Working Group, provided explanations of the history of the IPAC-RS efforts and their current activities in these areas. IPAC-RS will be posting these presentations on its web site beginning the week of April 4, 2011.
All of the afternoon talks focused on ensuring quality throughout the supply chain. The talks included updates on the activities of the IPAC-RS Supplier Quality and Materials Working Groups, a contract manufacturer’s perspective supplied by Ken Chesney of Flextronics, and a talk by Vibhakar Shah of the FDA. All of the talks will be available on the IPAC-RS web site.
Topics raised during the subsequent panel discussion included the need to develop and implement standards in the face of increasing globalization, the threat of counterfeit products, the use of statistical analysis, and the need to adapt to the rapid changes made possible by technology. Moderator Cheryl Stults prompted panel members to address the issue of “green” manufacturing and, in response to a question about the need to reduce redundant leachables and extractables testing required of suppliers, revealed that IPAC-RS and PQRI have collaborated on a leachables and extractables handbook scheduled to be published by Wiley and Sons next year.
After the panel, IPAC-RS chair Jackie Schumacher presented the poster awards, two of which went to engineers from MannKind Corporation. The awards went to:
First place: “Considerations for Human Factors in Developing a Pulmonary Drug/Device Delivery System,” Spencer Kinsey and Chad Smutney, MannKind Corporation.
Second place: “Design of Experiments to Optimize an In Vitro Nasal Cast,” Samir Shah, Merck
Third place: “Pressure Profiling in Development of a Dry Powder Delivery System,” Benoit Adamo and Chad Smutney, MannKind Corporation.
