欧盟GMP附录15《确认与验证》是欧盟药品生产质量管理规范（GMP）的重要组成部分，为制药行业提供了关于确认和验证活动的详细指导。该附录明确了确认和验证的范围、原则和要求，涵盖了从设备、设施到工艺和计算机化系统的整个生命周期管理。其核心目标是确保药品生产过程的可靠性和一致性，最终保障产品质量和患者安全。附录15强调基于科学和风险的方法，要求企业建立完善的验证计划并实施适当的控制措施。主要内容包括：验证主计划（VMP）、设计确认（DQ）、安装确认（IQ）、运行确认（OQ）、性能确认（PQ）、工艺验证（包括持续工艺验证）、清洁验证、分析方法验证以及变更控制等关键要素。EUGMPAnnex15"QualificationandValidation"isacriticalpartoftheEuropeanUnion'sGoodManufacturingPracticeguidelines,providingdetailedrequirementsforqualificationandvalidationactivitiesinthepharmaceuticalindustry.Itoutlinesthescope,principlesandrequirementsforvalidatingequipment,facilities,processesandcomputerizedsystemsthroughouttheirlifecycle.Theprimaryobjectiveistoensurethereliabilityandconsistencyofmanufacturingprocesses,ultimatelyguaranteeingproductqualityandpatientsafety.Theannexemphasizesascience-basedandrisk-basedapproach,requiringcompaniestoestablishcomprehensivevalidationplansandimplementappropriatecontrolmeasures.Keyelementsinclude:ValidationMasterPlan(VMP),DesignQualification(DQ),InstallationQualification(IQ),OperationalQualification(OQ),PerformanceQualification(PQ),ProcessValidation(includingContinuedProcessVerification),CleaningValidation,AnalyticalMethodValidation,andChangeControlamongothercriticalcomponents.
