How Can We Improve Quality in Inhalation Drug Products?

The podium presentations and discussion were recorded on April 25 at Respiratory Drug Delivery 2006 in Boca Raton, Florida to provide a broad perspective on 'Mitigating Producer Risk in a Highly Regulated Environment'. The session adds to the debate on appropriate ways to assess the quality of inhaled pharmaceutical products.

This regulatory session began with Drs Golden and Poochikian addressing the subjects of Process Analytical Technology (PAT) and Pharmaceutical Quality Assessment Systems (PQAS) as these relate to inhaled products. Subsequently, a panel of FDA, Health Canada and industry experts debated the merits of different approaches to decrease the risk of batch failures while maintaining or improving product quality.

This 2 hour electronic presentation has been made possible by the generous support of Boehringer Ingelheim.

What does PAT mean for Inhalation Products?
Michael H. Golden, Ph.D.,
GlaxoSmithKline, Research Triangle Park, NC

Audience discussion is included at the end of Dr Golden's presentation. Kevin Stapleton (Corus), Adrian Smith (Nektar) and Jagdeep Shur (University of Bath) agreed to the inclusion of their questions and comments.

Pharmaceutical Quality Assessment System (PQAS): Science and Risk Managed Approaches for Inhalation Drug Products
Guirag Poochikian, Ph.D.,
Food and Drug Administration, Silver Spring, MD.

Audience discussion is included at the end of Dr Poochikian's presentation. Jackie Schumacher (Pfizer) and Robert Berger (Schering-Plough) agreed to the inclusion of their questions and comments.

RDD 2006 Regulatory Debate: Mitigating Producer Risk in a Highly Regulated Environment.

The advocacy article published in the RDD 2006 Proceedings partners these presentations.

Mitigating Producer Risk in a Highly Regulated Environment.
Peter R. Byron, Ph.D.
Virginia Commonwealth University, Richmond, VA.

OINDP Component Suppliers: Selection, Development and Control.
Barbara Falco, B.S.
Kos Pharmaceuticals, Edison, NJ.

Mitigating Producer Risk in a Highly Regulated Environment: Statistical Considerations
J. David Christopher, Ph.D.
Schering-Plough Research Institute, Kenilworth, NJ.

Ensuring OINDP Quality: International Perspectives.
Caroline Vanneste, Ph.D.
Health Canada, Ottawa, Canada.

RDD 2006 Panel Discussion.

During the Panel Discussion at Respiratory Drug Delivery 2006, Stephen Horhota (Boehringer Ingelheim), Michael Riebe (RTI), Craig Dunbar (Alkermes), Kevin Stapleton (Corus), Stefan Leiner (Boehringer Ingelheim), Elaine Phillips (Verus) and Manfred Keller (Pari) agreed to the inclusion of their questions and comments.

Discussion Format:

• This discussion is presented as a series of audio lectures and synchronized powerpoint slides which were recorded and edited from Respiratory Drug Delivery 2006.
• RDD Online® have added slides to help summarize the issues discussed during the Q&A session with the audience.