刘双生Risk Based Approach 基于风险评价的设施、设备以及测量GMP审计

ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMP

Auditsparameters应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数一RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于风险的系统影响性评估和风险分类审计RiskBasedApproachofGMPAuditsFundamentalsofHVAC2.基于风险的空气净化系统GMP审计基本原则RiskBasedApproachofGMPAuditsFundamentalsof

PurifiedWaterGeneration/DistributionSystem3.基于风险的纯化水制备及储运系统GMP审计基本原则RiskBasedApproachof

GMPAuditsFundamentalsof

WaterforInjection

Generation/DistributionSystem4.基于风险的注射水制备及储运系统GMP审计基本原则RiskBasedApproachof

GMPAuditsFundamentalsof

compressedairsystems5.基于风险的压缩空气系统GMP审计基本原则RiskBasedApproachof

GMPAuditsFundamentalsof

MeasuringDevices6.基于风险的测量装置GMP审计基本原则ApplyriskmanagementprinciplestoidentifyDifferenttypesofproductsGMP

Auditsparameters(Facilities,EquipmentandMeasuringDevices)二应用风险管理原则来确定不同产品类型的GMP审计参数(设施、设备以及测量装置)RiskBasedApproachofGMPAuditsFundamentalsofTheoralsolidpreparation1.基于风险的口服制剂GMP审计基本原则RiskBasedApproachofGMPAuditsFundamentalsof

sterilepreparation2.基于风险的无菌制剂GMP审计基本原则RiskBasedApproachof

GMPAuditsFundamentalsof

biologicalproduct3.基于风险的生物制品GMP审计基本原则RiskBasedApproachof

GMPAuditsFundamentalsof

Chineseherbapreparation4.基于风险的中药制剂GMP审计基本原则三StandardOperatingProcedures(SOPs)1.标准操作规程CalibrationProgram2.校准计划PreventativeMaintenance3.预防性维护EnvironmentalMonitoring4.环境监测PersonnelTraining5.人员培训ChangeControl6.变更控制Revalidation再验证7.再验证ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于风险的系统影响性评估和风险分类审计Systemsimpactcategories1.1系统的影响类别directimpactsystem直接影响设备系统ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于风险的系统影响性评估和风险分类审计Systemsimpactcategories1.1

系统的影响类别ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于风险的系统影响性评估和风险分类审计Description描述SystemsimpactcategoriesDoesthesystem,comeindirectphysicalcontactwiththeproduct(e.g.,excipients,ingredients,solvents,orprocessingmaterials)at,orafter,acriticalprocessstep?在生产关键步骤时或之后，系统和产品（例如辅料、原料、溶剂、或加工材料）有直接接触？1.1

系统的影响类别•ImpactAssessment•

影响评估Doesthesystemdirectlyaffectproductquality(e.g.,thesystemcleans,sanitizes,sterilizesorthesystemmaintainsaclassifiedenvironment?系统对产品质量有直接影响（例如系统的清洁、消毒、灭菌或系统是用于维护某一有洁净级别要求的环境）？•Direct

Impact

AssessmenDoesthesystempreserveproductstatus?Isthesystemusedtostoreandpreservethestatus(e.g.,preservetemperature,humidity,etc.)ofinterimandfinalproductorproductsample?系统用于保持产品状态吗？

该系统是否用于储存和保持中间体、成品或产品的样品的状态（如，

保持温度、湿度，等）？•

直接影响性评估Doesthesystemproducedatathatisusedtoacceptorrejectproduct?系统是否产生用于接收或拒绝产品的数据？Isthesystemaprocesscontrolsystemthataffectsaproduct’ssafety,identity,strength,purityorqualityandthereisnosystemforindependentverificationofcontrolsystemperformanceinplace?该系统是否影响到产品安全、特性、浓度、纯度或安全的工艺控制系统，且没有一个对该控制系统性能进行独立确认的系统？Isthesystemusedtomanufactureorevaluatetosupportproductdispositionandregulatoryfillings?该系统是否用于生产或评估，以支持产品处置和药政报批？Doesthesystemcontrol,monitor,oralarmcriticalenvironmentalconditions?该系统是否用于重要环境条件的控制、监测或报警？ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于风险的系统影响性评估和风险分类审计Systemsimpactcategories1.1

系统的影响类别•ImpactAssessment•

影响评估•Direct

Impact

Assessment•

直接影响性评估Direct

Impact

System:

A

system

that

is

expected

tohave

a

direct

impact

to

the“product,”

on

theenvironmentalconditionswithincriticalroomsorchambers,and/ortheimpactontheintegrity

of

theGMP

documentation.

Thesesystemsare

designed

and

commissioned

in

line

with

Good

Engineering

Practice(GEP).

In

addition,

Direct

Impact

Systems

aresubjecttoQualificationPractices.直接影响系统：预计对“产品”有直接影响的系统，影响到重要房间或功能间的环境条件，及对GMP

体系的完整性有影响的系统。这些系统的设计和调试符合GEP。另外，对直接影响系统需要进行确认活动。ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数Validation

Following

Steps验证后续步骤Approve&FileDefineRequirements说明要求FinalReport

批准并将总结报告归档High/MidRisk

高／中风险PrepareDevelopProtocol准备验证方案RunValidation进行验证FMEA

/FinalReport准备总结报告QualityRiskAnalysis失效模式和影响分析(FMEA)/质量风险分析ValidationWaiverLowRisk验证豁免低风险ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于风险的系统影响性评估和风险分类审计Systemsimpactcategories1.1

系统的影响类别•ImpactAssessment•

影响评估•Direct

Impact

Assessment•

直接影响性评估DirectImpactSystemisthekeyoftheGMP

audit,inspection直接影响系统是GMP审计、核查的重点ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于风险的系统影响性评估和风险分类审计Systemsimpactcategories1.1

系统的影响类别•Direct

Impact

System•

直接影响系统SIP/CIPSystem在线灭菌/在线清洗系统SIP/CIPDistributionSystem在线灭菌/在线清洗分配系统TankWashControlSystem罐清洗控制系统ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于风险的系统影响性评估和风险分类审计Systemsimpactcategories1.1

系统的影响类别MANUFACTURINGEQUIPMENT生产设备•Direct

Impact

System•

直接影响系统LabelPrintingMachine标签印字机Cartoner纸盒包装机Checkweigher称重机FFULaminarBoothFFU层流罩MetalDetector金属检测器ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于风险的系统影响性评估和风险分类审计SystemsimpactcategoriesQualityControlequipment–ChemicalLaboratory1.1

系统的影响类别质量控制设备

化学试验室-•Direct

Impact

System•

直接影响系统TitratorwithcompleteKFtitrationmodule滴定仪Particlecounter粒子计数器Bulkdensitytester堆密度计Eccentricity离心机Climate-cabinet恒温恒湿箱TOCAnalyzerTOC

分析仪RotaryViscometer旋转粘度计VacuumOven真空干燥箱Muffle马弗炉Oven干燥箱Microscope显微镜ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于风险的系统影响性评估和风险分类审计Systemsimpactcategories1.1

系统的影响类别-QualityControlequipment–IPC质量控制设备

中间过程控制室•Direct

Impact

SystemDisintegrationtester崩解仪Friablilator脆碎度仪•

直接影响系统Hardnesstester硬度计Analyticalbalance分析天平Moisture

Analyzer快速水分测定仪ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于风险的系统影响性评估和风险分类审计SystemsimpactcategoriesQualityControlequipment–MicrobiologicalLaboratory1.1

系统的影响类别

质量控制设备–微生物试验室•Direct

Impact

System•

直接影响系统Balance天平Autoclave高压灭菌锅Laminarflowblend净化工作台Microbiologicalsafetycabinet生物安全柜Hotairsterilizer热风灭菌器Water

bath水浴Microscope显微镜Incubator培养箱ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于风险的系统影响性评估和风险分类审计ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于风险的系统影响性评估和风险分类审计ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于风险的系统影响性评估和风险分类审计ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于风险的系统影响性评估和风险分类审计ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于风险的系统影响性评估和风险分类审计ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于风险的系统影响性评估和风险分类审计ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于风险的系统影响性评估和风险分类审计ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于风险的系统影响性评估和风险分类审计ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于风险的系统影响性评估和风险分类审计•Assignmentoftheinspectionrating•

检查评定–Theoverallinspectionratingassignedisbasedontheriskinvolvedtakingintoaccountthenatureandextentofthedeviationswiththecategoryofproductsevaluated.–

综合评定基于存在的风险，缺陷的性质与程度以及评估产品的类别。ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于风险的系统影响性评估和风险分类审计Risk1(Critical)Observations1类风险（严重）缺陷ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于风险的系统影响性评估和风险分类审计Risk1(Critical)Observations1类风险（严重）缺陷•DirectImpactSystem•

直接影响系统•Equipment•

设备–-Equipmentusedforcomplexmanufacturingoperationsofcriticalproductsnotqualifiedandwithevidenceofmalfunctioning.–

用于最高风险产品复杂生产过程的设备不符合规定，同时存在不能保证生产现象。ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于风险的系统影响性评估和风险分类审计Risk2(Major)ObservationsApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于风险的系统影响性评估和风险分类审计Risk2(Major)Observations2类风险（主要）缺陷ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于风险的系统影响性评估和风险分类审计Risk2(Major)Observations2类风险（主要）缺陷ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于风险的系统影响性评估和风险分类审计2类风险（主要）缺陷DirectImpactSystem直接影响系统ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于风险的系统影响性评估和风险分类审计Risk2(Major)Observations2类风险（主要）缺陷ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于风险的系统影响性评估和风险分类审计Risk2(Major)Observations2类风险（主要）缺陷DirectImpactSystem直接影响系统ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationauditent

System1.基于风险的系统影响性评估和风险分类审计设施和设备系统DirectImpactSystem直接影响系统•

Facilities设施Majorconsiderationswhenevaluatingasepticprocessingoperations…对无菌工艺操作评估需要重要考虑的因素…•

Building

Management

System

(BMS)建筑管理系统（BMS）•

EnvironmentalControls(Temp,RH,DP)环境控制（温度、湿度、压差）•

Qualification

of

System

系统确认•

Maintenance/Calibration

of

system

and

sensors系统和传感器的维护/校准ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationauditent

System1.基于风险的系统影响性评估和风险分类审计设施和设备系统DirectImpactSystem直接影响系统•

Equipment设备–

Qualification

确认•

Initial

初始确认•

Re-evaluation

--

after

changes

再确认-变更发生后*(Change

Control

Documentation)

*(变更控制文件)–

Preventive

Maintenance

/

Calibration预防性维护/校准•

SOP

dictates

schedule

or

software

programSOP规程或软件程序ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationauditent

System1.基于风险的系统影响性评估和风险分类审计设施和设备系统DirectImpactSystem直接影响系统•

Equipment设备–

Cleaning

Validation

清洁验证•

Establishing

Limits建立限度•

Recovery

Studies回收率研究•

Executed

Protocol执行方案Quality

systems

to

support质量系统的支持DirectImpactSystem直接影响系统•

Changemanagement•

ChangerequestsincludingRiskAssessment•

变更管理•

包括风险评估的变更申请•

变更之后的流程，平面图和文•

Changedprocess,layouts件anddocumentation•

Qualification/Validation•

Validation

Plan•

URS•

确认/验证•

验证计划•

用户需求标准•

IQ/OQ•

安装确认/运行确认•

静态环境验证/环境监测•

培养基灌装试验•

PQforEnvironment/Environmentalmonitoring•

PST•

DeviationManagement•

QualityRiskAssessment•

偏差管理•

质量风险评估ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数RiskBasedApproachofGMPAuditsFundamentalsofHVAC2.基于风险的空气净化系统GMP审计基本原则关键组件分析确定审计重点CriticalComponent

Assessment(CCA)todeterminetheauditfocusComponentCriticality

Assessment:

Thecomponentcriticalityassessmentisusedtoassesstherisksassociatedtothecriticalcomponentsofdirectimpactsystemstodeterminetheirrisklevelsintheentiresystemandtoproposecontrolmeasurestoreducetheserisks.部件关键性评估(CCA)：通过对“直接影响系统”的关键性部件进行风险评估，确定其在整个系统中的风险程度，并建议控制措施降低其风险。ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数RiskBasedApproachofGMPAuditsFundamentalsofHVAC2.基于风险的空气净化系统GMP审计基本原则关键组件分析确定审计重点CriticalComponent

Assessment(CCA)todeterminetheauditfocusAccordingtotheassessment,componentswillbeclassifiedascriticalornotcritical.通过评估,部件都归类为关键和非关键两种.Theclassificationisgoingtobedonebasedonthefollowingquestions.这种归类将根据下列问题进行.Iftheansweris“yes”toanyofthe7questions,thecomponentisclassifiedascritical.七个问题中只要有一个问题的答案是“Yes”，就将该部件归类为关键的部件。ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数RiskBasedApproachofGMPAuditsFundamentalsofHVAC2.基于风险的空气净化系统GMP审计基本原则关键组件分析确定审计重点CriticalComponent

Assessment(CCA)todeterminetheauditfocus•1-部件是否与产品、产品成分或产品内包材直接接触？Doesthecomponenthavedirectcontactwiththeproduct,productingredientsorproductinnerpackaging?•2-与产品接触的设备在清洗或消毒时需要使用溶剂，部件是否与这些溶剂或/和这些溶剂的配料有接触？Isthecomponent

in

contact

with

solvent,

or/and

their

ingredients,

used

toclean

or

to

sterilize

equipment

in

contactwiththeproduct?•3-部件的正常操作或控制对产品质量或功效具有直接的影响？Doesthenormaloperationorcontrolofthecomponenthaveadirecteffectonproductqualityorefficacy?•4-部件是否用于获得，维护或测量/控制可以影响产品质量的关键工艺参数，而对控制系统性能无独立的验证？Does

thecomponent/function

control

critical

process

elements

that

may

affect

product

quality

without

independentverificationofthecontrolsystemperformance?•5-部件的故障或报警是否对产品质量或功效具有直接影响？Doesthefailureoralarmofthecomponent/functionhaveadirecteffectonproductqualityorefficacy?•6-从部件获取的信息被记录为批记录、批放行数据或其它GMP相关文件的一部分？Istheinformationfrom

this

component

recorded

as

part

of

thebatch

record,

lot

release

data,

or

otherGMP

relateddocumentation?•7-部件用于创建或保持某种系统的关键状态？Isthecomponentusedtocreateorpreserveacriticalstatusofsystem?ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数RiskBasedApproachofGMPAuditsFundamentalsofHVAC2.基于风险的空气净化系统GMP审计基本原则关键组件分析确定审计重点CriticalComponent

Assessment(CCA)todeterminetheauditfocusApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数RiskBasedApproachofGMPAuditsFundamentalsofHVAC2.基于风险的空气净化系统GMP审计基本原则关键组件分析确定审计重点CriticalComponent

Assessment(CCA)todeterminetheauditfocusApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数RiskBasedApproachofGMPAuditsFundamentalsofHVAC2.基于风险的空气净化系统GMP审计基本原则关键组件分析确定审计重点CriticalComponent

Assessment(CCA)todeterminetheauditfocusApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数RiskBasedApproachofGMPAuditsFundamentalsofHVAC2.基于风险的空气净化系统GMP审计基本原则关键组件分析确定审计重点CriticalComponent

Assessment(CCA)todeterminetheauditfocusHVACSystemtodeterminetheauditfocus空调净化系统系统审计重点解析案例

空调净化系统系统审计重点解析.docAirConditioningAutomaticControlSystemtodeterminetheauditfocus空调自控系统审计重点解析案例

空调自控系统审计重点解析.docParticleMonitoring

Systemtodeterminetheauditfocus粒子监测系统审计重点解析案例

粒子监测系统审计重点解析.docApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数RiskBasedApproachofGMPAuditsFundamentalsof

PurifiedWaterGeneration/DistributionSystem3.基于风险的纯化水制备及储运系统GMP审计基本原则PurifiedWater

Generation/DistributionSystem纯化水制备及储运系统Maincomponents:主要部件：ActivatedCarbonFilter,

Heatexchanger,ReverseOsmosis,EDI.活性炭过滤器，热交换器，反渗透、EDI。PWS&DSystemRA纯化水储存与分配系统风险分析ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数RiskBasedApproachofGMPAuditsFundamentalsof

PurifiedWaterGeneration/DistributionSystem3.基于风险的纯化水制备及储运系统GMP审计基本原则关键组件分析确定审计重点CriticalComponent

Assessment(CCA)todeterminetheauditfocusComponentCriticality

Assessment:

Thecomponentcriticalityassessmentisusedtoassesstherisksassociatedtothecriticalcomponentsofdirectimpactsystemstodeterminetheirrisklevelsintheentiresystemandtoproposecontrolmeasurestoreducetheserisks.部件关键性评估(CCA)：通过对“直接影响系统”的关键性部件进行风险评估，确定其在整个系统中的风险程度，并建议控制措施降低其风险。ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数RiskBasedApproachofGMPAuditsFundamentalsof

PurifiedWaterGeneration/DistributionSyst3.基于风险的纯化水制备及储运系统GMP审计基本原则关键组件分析确定审计重点CriticalComponent

Assessment(CCA)todeterminetheauditfocusPurifiedWater

Generation

Systemtodeterminetheauditfocus纯化水制备系统审计重点解析案例

纯化水制备系统审计重点解析.doc通过验证纯化水系统的IQ看审计.docPurifiedWater

DistributionSystem

Systemtodeterminetheauditfocus纯化水储运系统审计重点解析案例案例GMP检查之SOP纯化水监测.docPurifiedWater

AutomaticControlSystem

todeterminetheauditfocus纯化水自动控制系统审计重点解析案例

纯化水自动控制系统审计重点解析.docApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数RiskBasedApproachof

GMPAuditsFundamentalsof

WaterforInjection

Generation/DistributionSystem4.基于风险的注射水制备及储运系统GMP审计基本原则关键组件分析确定审计重点CriticalComponent

Assessment(CCA)todeterminetheauditfocusApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数RiskBasedApproachof

GMPAuditsFundamentalsof

WaterforInjection

Generation/DistributionSystem4.基于风险的注射水制备及储运系统GMP审计基本原则坡度正压取样循环流速正压液位，联机呼吸器，无泄漏喷淋排放温度坡度排净空气隔断ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数RiskBasedApproachof

GMPAuditsFundamentalsof

WaterforInjection

Generation/DistributionSystem4.基于风险的注射水制备及储运系统GMP审计基本原则关键组件分析确定审计重点CriticalComponent

Assessment(CCA)todeterminetheauditfocusWater

forInjection

Generation

Systemtodeterminetheauditfocus注射水制备系统审计重点解析案例

注射水制备系统审计重点解析.docWater

forInjectionDistributionSystem

Systemtodeterminetheauditfocu注射水储运系统审计重点解析案例

注射水储运系统审计重点解析.docWater

forInjectionAutomaticControlSystem

todeterminetheauditfocus注射水自动控制系统审计重点解析案例

注射水自动控制系统审计重点解析.docApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数RiskBasedApproachof

GMPAuditsFundamentalsof

compressedairsystems5.基于风险的压缩空气系统GMP审计基本原则关键组件分析确定审计重点CriticalComponent

Assessment(CCA)todeterminetheauditfocuscompressedairsystemstodeterminetheauditfocus压缩空气系统审计重点解析--注意通往与产品直接接触的气体的除菌过滤情况的审计案例

压缩空气系统审计重点解析.docApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、应用风险管理原则来确定设施、设备以及测量装置的GMP审计参数RiskBasedApproachof

GMPAuditsFundamentalsof

MeasuringDevices6.基于风险的测量装置GMP审计基本原则Risk

Based

Approach

of

System

ImpactAssessment

(SIA)

and

Risk

classification基于风险的系统影响性评估和风险分类审计MeasuringDevicestodeterminetheauditfocus测量装置审计重点解析案例

测量装置审计重点解析.doc注意直接影响系统和设备仪器的法定效验周期以及企业效验或者周检计划的真实性ApplyriskmanagementprinciplestoidentifyDifferenttypesofproductsGMPAuditsparameters(Facilities,EquipmentandMeasuringDevices)二、应用风险管理原则来确定不同产品类型的GMP审计参数(设施、设备以及测量装置)RiskBasedApproachofGMPAuditsFundamentalsofTheoralsolidpreparation1.基于风险的口服制剂GMP审计基本原则ApplyriskmanagementprinciplestoidentifyDifferenttypesofproductsGMPAuditsparameters(Facilities,EquipmentandMeasuringDevices)二、应用风险管理原则来确定不同产品类型的GMP审计参数(设施、设备以及测量装置)RiskBasedApproachofGMPAuditsFundamentalsofTheoralsolidpreparation1.基于风险的口服制剂GMP审计基本原则ApplyriskmanagementprinciplestoidentifyDifferenttypesofproductsGMPAuditsparameters(Facilities,EquipmentandMeasuringDevices)二、应用风险管理原则来确定不同产品类型的GMP审计参数(设施、设备以及测量装置)RiskBasedApproachofGMPAuditsFundamentalsofTheoralsolidpreparation1.基于风险的口服制剂GMP审计基本原则制粒工艺检查全机械提升式ApplyriskmanagementprinciplestoidentifyDifferenttypesofproductsGMPAuditsparameters(Facilities,EquipmentandMeasuringDevices)二、应用风险管理原则来确定不同产品类型的GMP审计参数(设施、设备以及测量装置)RiskBasedApproachofGMPAuditsFundamentalsofTheoralsolidpreparation1.基于风险的口服制剂GMP审计基本原则颗粒剂生产线连线连续多锅湿法制粒烘干重点考察此系统的工艺验证情况ApplyriskmanagementprinciplestoidentifyDifferenttypesofproductsGMPAuditsparameters(Facilities,EquipmentandMeasuringDevices)二、应用风险管理原则来确定不同产品类型的GMP审计参数(设施、设备以及测量装置)RiskBasedApproachofGMPAuditsFundamentalsofTheoralsolidpreparation1.基于风险的口服制剂GMP审计基本原则ApplyriskmanagementprinciplestoidentifyDifferenttypesofproductsGMPAuditsparameters(Facilities,EquipmentandMeasuringDevices)二、应用风险管理原则来确定不同产品类型的GMP审计参数(设施、设备以及测量装置)RiskBasedApproachofGMPAuditsFundamentalsofTheoralsolidpreparation1.基于风险的口服制剂GMP审计基本原则ApplyriskmanagementprinciplestoidentifyDifferenttypesofproductsGMPAuditsparameters(Facilities,EquipmentandMeasuringDevices)二、应用风险管理原则来确定不同产品类型的GMP审计参数(设施、设备以及测量装置)RiskBasedApproachofGMPAuditsFundamentalsofTheoralsolidpreparation1.基于风险的口服制剂GMP审计基本原则ApplyriskmanagementprinciplestoidentifyDifferenttypesofproductsGMPAuditsparameters(Facilities,EquipmentandMeasuringDevices)二、应用风险管理原则来确定不同产品类型的GMP审计参数(设施、设备以及测量装置)RiskBasedApproachofGMPAuditsFundamentalsofTheoralsolidpreparation1.基于风险的口服制剂GMP审计基本原则制粒工艺检查自动化控制

审查其计算机系统是否验证以及批记录打印附件与工艺验证对比ApplyriskmanagementprinciplestoidentifyDifferenttypesofproductsGMPAuditsparameters(Facilities,EquipmentandMeasuringDevices)二、应用风险管理原则来确定不同产品类型的GMP审计参数(设施、设备以及测量装置)RiskBasedApproachofGMPAuditsFundamentalsofTheoralsolidpreparation1.基于风险的口服制剂GMP审计基本原则ApplyriskmanagementprinciplestoidentifyDifferenttypesofproductsGMPAuditsparameters(Facilities,EquipmentandMeasuringDevices)二、应用风险管理原则来确定不同产品类型的GMP审计参数(设施、设备以及测量装置)RiskBasedApproachofGMPAuditsFundamentalsofTheoralsolidpreparation1.基于风险的口服制剂GMP审计基本原则ApplyriskmanagementprinciplestoidentifyDifferenttypesofproductsGMPAuditsparameters(Facilities,EquipmentandMeasuringDevices)二、应用风险管理原则来确定不同产品类型的GMP