PQRI-FDA研讨会漂移过程程序.pdf

PQRI-FDA Workshop on Process Drift: Detection, Measurement, and Control in the Manufacture of Pharmaceuticals December 1-3, 2010 Bethesda, Maryland Please note start time on December 1 has changed. SCOPE AND OBJECTIVES FOR THE WORKSHOP PLANNING COMMITTEE MEMBERS Early understanding of the major sources of variation is essential to Richard L. Friedman , CDER Office of Compliance, U.S. Food and sound process design and establishing a dependable manufacturing Drug Administration, process. Over time, a drug ingredient or finished drug manufacturing Co-chair process may drift from its target due to intrinsic or extrinsic factors that Rajendra (Raj) Uppoor, R.Ph., Ph.D., CDER Office of Pharmaceutical are either initially unknown or considered to be of lesser significance. Science, U.S. Food and Drug Administration, Systems for routine evaluation of manufacturing performance are funda- Co-chair mental to maintain an ongoing state of control. Failure to adequately Avraham (Avi) Yacobi, Ph.D., Taro Pharmaceuticals, control processes and prevent defects can potentially pose a significant Co-chair risk to consumers, affect product availability, and yield undesirable reg- ulatory and business outcomes. Prabir K. Basu, Ph.D., National Institute for Pharmaceutical Technology and Education (NIPTE) (a) discuss a lifecycle approach to monitoring manufacturing Frank Holcombe, Jr., Ph.D., CDER Office of