Process Analytical Technologies Subcommittee of the

Advisory Committee for Pharmaceutical Science

Holiday Inn, 2 Montgomery Village Avenue

Gaithersburg, MD

February 25-26 2002

Backgrounder Contents

Overview - The ACPS’s Process Analytical Technology Subcommittee

Ajaz S. Hussain, Ph. D., FDA

FDA Regulation of Drug Quality: New Challenges

Janet Woodcock, M.D., FDA

Pharmaceutical Manufacturing: New Technology Opportunities..

G.K. Raju, Ph.D., MIT

Emerging Science Issues in Pharmaceutical Manufacturing: Process Analytical Technologies

Ajaz S. Hussain, Ph. D., FDA

An Industry Perspective on the Potential for Emerging Process Analytical Technologies

Norman Winskill and Steve Hammond, Pfizer Global Manufacturing

Total Quality Management System (TQMS) AstraZeneca Solid Dosage Facility

Ali Afnan, AstraZeneca

Productivity and the Economics of Regulatory Compliance in Pharmaceutical Production

Doug Dean and Frances Bruttin, PricewaterhouseCoopers Consulting

Real Time Quality Control (Batch Monitoring) of Pharmaceutical Production Processes

Chris Ambrozic and John Parsons, Umetrics Inc.

Note for Guidance on Parametric Release

The European Agency for the Evaluation of Medicinal Product

Committee for Proprietary Medicinal Products; London, 1 March 2001

Note for Guidance on the Use of Near Infrared Spectroscopy by the Pharmaceutical Industry

and the Data to be Forwarded in Part II of the Dossier for a Marketing Authorization

The European Agency for the Evaluation of Medicinal Product

Committee for Proprietary Medicinal Products

Committee for Veterinary Medicinal Products; London, 14 November 2001