CDERRisk-basedSiteSelectionModelAnFDARisk.pptVIP

FDA Science Board Nov 5, 2004 CDER Risk-based Site Selection Model: An FDA Risk Management Tool Presentation to FDA Science Board November 5, 2004 by Kara Morgan, Ph.D., Office of Planning/Office of the Commissioner Upgrading FDA Risk Management Tools FDA is interested in formalizing risk management tools Rigorous, science-based methods are available Commissioner’s Strategic Plan – Efficient Risk Management Difficult to evaluate efficiency when risk management tools are not formalized OMB Oversight Transparency, Consistency, Accuracy Risk as a meaningful public health metric Motivation for the CDER Risk-based Site Selection Model Previous (pre FY05) approach CDER identified “high-risk” as sterile drugs, Rx drugs, new registrants, exclude medical gas ORA decided where to go within those categories Problems Insufficient resources to inspect all sites “High-risk” category wasn’t discriminating enough CDER wanted to incorporate additional information Solution: a formal model to rank sites by risk Note: Before the use of the model, decisions were risk-based but not formalized. Risk-related knowledge was incorporated by the field. Process for Model Development Working group established under CGMP: CDER, CBER, CVM, ORA and OC Defined risk; brainstormed risk factors Risk = harm to patient from low quality product Categorized factors into three bins: product-related, process-related, facility-related Evaluated available data for assessing these factors Developed weights for the factors Product-related Factors Intrinsic factors Sterility Prescription Recall data By product class Includes measure of severity Facility-related Factors History Time elapsed since last inspection Compliance and Violation record Estimated production volume Establishment type (i.e., manufacture, repacking, relabeling, testing, sterilizing) Source of data: FACTS (Field Accomplishments and Compliance Tracking System) Process-related Factors Inherent Process Risk Factors, including potential for c