AAPS Workshop on Pharmaceutical Quality Assessment - A Science and Risk-based CMC Approach in the 21st Century Oct 5-7, 2005 - Maryland

AAPS Workshop on Pharmaceutical Quality Assessment - A Science and Risk-based CMC Approach in the 21st Century
Co-sponsored with FDA and ISPE
Oct 5-7, 2005
Bethesda North Marriott
North Bethesda, Maryland
Goals and Objectives
Consistent with the CGMPs for the 21st Century Initiative, FDA is establishing a modern, risk-based pharmaceutical quality assessment system to replace the current chemistry, manufacturing, and controls (CMC) review system. The new quality assessment system is intended to facilitate innovation and continuous improvement throughout the product lifecycle and to provide regulatory flexibility for specification setting and post-approval changes based on scientific knowledge and understanding of product and process by applying quality-by-design principles and to expedite the review of drug applications without compromising the high quality of drugs in the United States. Plenary sessions will present scientific and technical challenges to provide the framework for discussions in the breakout sessions. Breakout sessions will serve as the forum for FDA to seek input from the public in understanding the pros and cons of the various aspects and in identifying alternative approaches to achieve the desired state. Specifically, the workshop will:
explore and evaluate all facets of the new pharmaceutical quality assessment system;
define what is meant by a risk-based system and how to establish criteria to identify and measure risk associated with the development and manufacturing of pharmaceutical drug products;
assess the roles and value of Pharmaceutical Development Information, Quality Overall Summary, and integrated review/inspection functions in the new paradigm;
examine the kind, amount and extent of data in future CMC submissions and its value in making science-based regulatory decisions;
develop appropriate strategies to submit and to assess critical manufacturing science information to facilitate PAT, and to encourage innovation in pharmaceutical manufacturing;
determine how to set product specifications in the new paradigm based on recommendations and findings of PQRI Workshop (March 2005); and
identify the roles of industry and FDA to facilitate continuous product and process improvement.
Desired Outcomes
In addition to providing a better understanding of the critical elements of the new regulatory system, this workshop will provide the following:
identification of scientific training gaps that must be filled for the successful implementation of the new system;
industry input to FDA to influence the establishment of a scientific risk-based regulatory system that maintains high quality and facilitates continuous improvement;
help determine implementation strategies on how to utilize pharmaceutical development information and quality overall summary in the new system (submission and review);
identify the roles and responsibilities of industry and regulators in the new paradigm;
a written document that could serve as the basis for development of regulatory guidance; and
propose ways to reduce the number of post-marketing supplements.