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