-
PDD Open Forum
Understanding the Impact of FDA's Quality by Design Initiative on Establishment of Drug Product Specification
Saturday, November 10
8:00 am – 5:00 pm
Background Information
In August 2002, the U.S. Food and Drug Administration (FDA) announced a new initiative – Pharmaceutical cGMPs for the 21 st Century: A Risk-Based Approach – intended to enhance and modernize pharmaceutical manufacturing and the Chemistry, Manufacturing, and Controls (CMC) regulatory process. The pharmaceutical cGMPs for the 21 st Century initiative envisions a future in which FDA recognizes that manufacturers have the ability to use process variables to control product attributes and therefore allows manufacturing changes to be made with less restrictive oversight.
Transformation of the CMC review into a modern, science and risk-based pharmaceutical quality assessment is underway. The FDA Office of New Drug Quality Assessment (ONDQA) developed a new Pharmaceutical Quality Assessment System (PQAS) to assess a sponsors implementation of Quality by Design (QbD). The ONDQA’s Pilot Program was launched in July 2005 and has over 11 new drugs sponsors enrolled with 2 approvals as of Feb 2007. During the same timeframe, the FDA Office of Generic developed Question-based Review (QbR) as an Abbreviated New Drug Application (ANDA) review framework that is focused on critical pharmaceutical quality attributes. The FDA Office of Biotechnology Products has investigated the application of QbD for biotech and biological products.
As the pharmaceutical industry applies QbD concepts to development and manufacturing activities, it is imperative that there is open dialogue about how drug product specifications are established in the new QbD initiatives. This workshop will focus on how pharmaceutical development knowledge changes the establishment of specifications for dissolution and impurities.
Goals and Objectives:
During the course of this open forum we will:
- Understand FDA’s Quality by Design (QbD) Initiative
- Describe the Impact of QbD on Dissolution Specification
- Explain the Effect of QbD on Impurity Specification
- Discuss the Impact of QbD on Quality Specification of Biotech Products
Program
Introduction
James Polli, Ph.D.
University of Maryland
FDA’s Pharmaceutical QbD Initiative
Moheb Nasr, Ph.D.
U.S. Food and Drug Adminstration
Impact of QbD on Dissolution Specification for New Drugs: An Industry Perspective
Qingxi Wang, Ph.D
Merck and Company, Inc.
Impact of QbD on Dissolution Specification for New Drugs: An FDA Perspective
Arzu Selen, Ph.D.
U.S. Food and Drug Administration
Break
Impact of QbD on In Vitro and In Vivo Correlations: Case Study
Sanjay Sehgal, Ph.D.
Wyeth Research
QbD Perspectives on Dose Dumping with Clinical Consequences: Significance of Mechanistic Understanding.
Mansoor Khan, Ph.D.
U.S. Food and Drug Administration
Open Discussion (Morning Speakers)
Lunch
Question-based Review for Generic Drugs: An Industry Perspective
Francois Menard, Ph.D.
Sandoz
Impact of QbD on Impurity Specification for Generic Drugs: An Industry Perspective
John Kovaleski, Ph.D.
Teva Pharmaceuticals
Impact of QbD on Impurity Specification for Generic Drugs: An FDA Perspective
Paul Schwartz, Ph.D
U.S. Food and Drug Administration
Break
Impact of QbD on Quality Specification of Biotech Products: An Industry Perspective
Speaker to be Announced
Impact of QbD on Quality Specification of Biotech Products: An FDA Perspective
Steven Kozlowski, M.D.
U.S. Food and Drug Administration
Open Discussion (Afternoon Speakers)
Adjournment
An additional fee is required to attend the PDD Open Forum. To register, select the appropriate registration fee under the Special Events section of the registration form.
Back to Top