上海CMC培训 FDA Manufacturing Facility Inspection Programs.pptxVIP

FDA Manufacturing Facility Inspection ProgramsJim Li, Ph.D. MBAJune 29, 2010Presentation Overview Types of inspections 检查类型Pre-approval inspection (PAI) process 药品批准前检查程序FDA’s Expectations in CGMP Compliance FDA 对CGMP合规性方面的预期和要求Cases 案例Types of GMP InspectionsGMP检查类型Type of Inspection 检查类型Surveillance Inspections 常规 GMP 监测检查For-Cause Inspections 原因引起的GMP检查Pre-approval Inspections 药品批准前GMP检查System Based Inspection系统GMP检查Surveillance Inspections常规 GMP 监测检查Full Inspection 全面检查A broad and deep evaluation of the firm‘s CGMP complianceConducted when Little or no information is knownThere is doubt about the CMGP compliance in the firmFollow up to previous regulatory actions. At least four systems, one must be Quality System Surveillance Inspections常规 GMP 监测检查Abbreviated Inspection 简略检查An update evaluation of a firm’s CGMPConducted when a firm hasa record of satisfactory CGMP complianceno significant recall (召回), product defect (缺陷) or incidents (事故)little shift in the manufacturing profiles within last two yearsAt least two systems, one must be Quality SystemOptional systems are rotated in next Inspections. For a contract lab, two systems may be considered a Full InspectionSurveillance Inspections常规 GMP 监测检查Post-Approval Inspection 批准后检查Audit for changes in the production and control practices that occur after approval Confirm that the approved applications have been appropriately supplemented to reflect those changesCover approved products regardless of whether or not these products were covered under the pre-approval programSignificant Problems Found in Post-Approval Audit批准后检查中发现的一些主要问题Scale up not documented/validated prior to commercial distributionLack of data supporting processes and controls, and changes theretoLack of controls and recordsInadequate, or lack of, validationInadequate change control proceduresUnauthorized process changesInadequate stability data, unfulfilled stability testing commitments, Unreported stability test failuresSignificant Problems Fou