FDA产品质量的风险评估原则RiskAssessmentPrinciplesfortheProductQualitynitiatives.pptVIP

Risk Assessment Principles for the Product Quality Initiatives H. Gregg Claycamp, Ph.D., CHP Center for Veterinary Medicine Office of New Animal Drug Evaluation hclaycam@cvm.fda.gov June 25, 2003 Outline Overall Premise and Questions Basics of Risk Analysis Possible Stages of Risk Assessments for PQ Initiatives Risk Ranking Model for a PQ Initiative? Pilot Scale Conclusions Premise: Links Among Process (GMP) Risks and Patient Risks are Lost Goal: Re-Link cGMP (PQ) Risks with Actual Risks to the Patient The Question… Can Risk Management theory, tools, practice and philosophy be employed to re-link risks to the patient with the risks identified, perceived or otherwise implicated in product quality terms? How can we share a common language about risk, risk management,and science-based decision making so that we can focus on developing a high-quality risk management model for product quality? Getting Started… What theories, tools and lessons learned in risk analysis can help address these questions? Given the need for a significant shift in the approach to risk management, how do we begin the change process? Are there off-the-shelf models and tools that might be used, i.e., at a pilot-scale? What kinds of RM processes can be used to foster changes needed both the regulatory and industrial spheres? Basic Risk Analysis Starting with the Some Basics Risk is intuitive and familiar to everyone, yet few among us define risk carefully and formally enough for complex risk analysis. Risk = “exposure to a chance of loss” (or, Risk = “chance of losing something we value”) Contemporary Risk Analysis Includes four major activities: Hazard Identification Risk Assessment Risk Management Risk Communication Risk Assessment Precedes Risk Management Risk assessment is not a single process, but “a systematic approach to organizing and analysing scientific knowledge and information” to support a risk decision. NRC (1994) Various paradigms exist for the execution of a