AjazS.Hussain,Ph.D.DeputyDirectorOfficeofPharmac.pptVIP

PAT Initiative: Next Steps Ajaz S. Hussain, Ph.D. Deputy Director Office of Pharmaceutical Science, CDER, FDA PAT Initiative FDA Science Board Meetings (11/01, 4/02) Emerging Science Issues in Pharmaceutical Manufacturing Current state of Pharmaceutical Manufacturing G. K. Raju (M.I.T) and Doug Dean (PriceWaterHouseCoopers) Opportunities for improvements Norman Winskill and Steve Hammond (Pfizer) New Technology - “Don’t Use” or “Don’t Tell” approach Ray Scherzer (CAMP/GlaxoSmithKline) Challenge to Phrama Industry - Quality By Design Science Board support for FDA’s proposal to facilitate innovation PAT Progress Advisory Committee for Pharmaceutical Science (PAT Subcommittee) deliberations Definitions, benefits, and scope Perceive/real regulatory “hurdles” Internal (with-in company) “hurdles” Need for across discipline communication Pharmacy+Chemistry+Engineering = Pharmaceutical Engineering Approaches for removing these “hurdles” Case studies General approaches for validation PAT Training curriculum for FDA staff PAT Teams: ORA, CDER CVM Why Process Analytical Technologies? PAT provides an opportunity to move from the current “testing to document quality” paradigm to a “Continuous Quality Assurance” paradigm that can improve our ability to ensure quality was “built-in” or was “by design” - ultimate realization of the true spirit of cGMP! Greater insight and understating of processes At/On/In-line measurement of “performance” attributes Real-time or rapid feedback controls (focus on prevention) Potential for significant reduction in production and development cycle time Minimize risks of poor process quality and reduce (regulatory) concerns PAT Conceptual Framework for Regulatory Policy Development Product and Process Quality Knowledge: Science-Risk Based cGMP’s Regulatory Framework PAT tools not a requirement Research exemption Continuous improvement without the fear of being considered non-compliant Regulatory support and flexibility during development imp