Food and Drug Administration

Center for Drug Evaluation and Research


Advisory Committee for Pharmaceutical Science

Manufacturing Subcommittee


Gaithersburg Marriott - Washingtonian Center

9751 Washingtonian Boulevard

Gaithersburg, Maryland 20878


DRAFT Agenda                                                                                  May 21-22, 2003


8:30             Call to Order and Opening Remarks                            


                    Introduction of Committee


                    Conflict of Interest Statement                                                        


8:45             Introduction                                                                    



Pharmaceutical cGMPs for the 21st  Century: a Risk-Based Approach


9:15             FDA Perspective                                                              


10:15            Break


10:30            Academic Perspective                                              


11:30            Open Public Hearing


12:30            Lunch


1:30             GPhA Pespective                                                             


                    PhRMA Perspective                                                        


2:30             Development of subcommittee work plan                        


                    Purpose and mission of subcommittee


                    Questions to Subcommittee


                    Subcommittee Discussion


3:00             Break


4:30             Adjourn


Thursday, May 22, 2003


8:30      Call to Order and Opening Remarks                                           


            Introduction of Committee


            Conflict of Interest Statement                                    



Transition from Process Analytical Technologies (PAT) Subcommittee to

Manufacturing Subcommittee


8:40      Role of PAT in GMP Initiative                                               


Changes without prior approval - FDA perspective                             


10:00    Break


10:15    Perspective on risk analysis for the GMP Initiative                 


            Manufacturing and risk                                                          


11:30    Open Public Hearing


12:30    Lunch


Update - Regulatory approaches regarding aseptic manufacturing


1:30      Issues and future plans                                                


            PQRI Aspect                                                                           


2:30        Break


2:45      Subcommittee next steps                                                         


4:15      Conclusions and Summary Remarks                                     


4:30      Adjourn