劉雙生Risk Based Approach 基于風險評價的設施、設備以及測量GMP審計

ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMP

Auditsparameters應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)一RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統(tǒng)影響性評估和風險分類審計RiskBasedApproachofGMPAuditsFundamentalsofHVAC2.基于風險的空氣凈化系統(tǒng)GMP審計基本原則RiskBasedApproachofGMPAuditsFundamentalsof

PurifiedWaterGeneration/DistributionSystem3.基于風險的純化水制備及儲運系統(tǒng)GMP審計基本原則RiskBasedApproachof

GMPAuditsFundamentalsof

WaterforInjection

Generation/DistributionSystem4.基于風險的注射水制備及儲運系統(tǒng)GMP審計基本原則RiskBasedApproachof

GMPAuditsFundamentalsof

compressedairsystems5.基于風險的壓縮空氣系統(tǒng)GMP審計基本原則RiskBasedApproachof

GMPAuditsFundamentalsof

MeasuringDevices6.基于風險的測量裝置GMP審計基本原則ApplyriskmanagementprinciplestoidentifyDifferenttypesofproductsGMP

Auditsparameters(Facilities,EquipmentandMeasuringDevices)二應用風險管理原則來確定不同產(chǎn)品類型的GMP審計參數(shù)(設施、設備以及測量裝置)RiskBasedApproachofGMPAuditsFundamentalsofTheoralsolidpreparation1.基于風險的口服制劑GMP審計基本原則RiskBasedApproachofGMPAuditsFundamentalsof

sterilepreparation2.基于風險的無菌制劑GMP審計基本原則RiskBasedApproachof

GMPAuditsFundamentalsof

biologicalproduct3.基于風險的生物制品GMP審計基本原則RiskBasedApproachof

GMPAuditsFundamentalsof

Chineseherbapreparation4.基于風險的中藥制劑GMP審計基本原則三StandardOperatingProcedures(SOPs)1.標準操作規(guī)程CalibrationProgram2.校準計劃PreventativeMaintenance3.預防性維護EnvironmentalMonitoring4.環(huán)境監(jiān)測PersonnelTraining5.人員培訓ChangeControl6.變更控制Revalidation再驗證7.再驗證ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統(tǒng)影響性評估和風險分類審計Systemsimpactcategories1.1系統(tǒng)的影響類別directimpactsystem直接影響設備系統(tǒng)ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統(tǒng)影響性評估和風險分類審計Systemsimpactcategories1.1

系統(tǒng)的影響類別ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統(tǒng)影響性評估和風險分類審計Description描述SystemsimpactcategoriesDoesthesystem,comeindirectphysicalcontactwiththeproduct(e.g.,excipients,ingredients,solvents,orprocessingmaterials)at,orafter,acriticalprocessstep?在生產(chǎn)關鍵步驟時或之后，系統(tǒng)和產(chǎn)品（例如輔料、原料、溶劑、或加工材料）有直接接觸？1.1

系統(tǒng)的影響類別?ImpactAssessment?

影響評估Doesthesystemdirectlyaffectproductquality(e.g.,thesystemcleans,sanitizes,sterilizesorthesystemmaintainsaclassifiedenvironment?系統(tǒng)對產(chǎn)品質(zhì)量有直接影響（例如系統(tǒng)的清潔、消毒、滅菌或系統(tǒng)是用于維護某一有潔凈級別要求的環(huán)境）？?Direct

Impact

AssessmenDoesthesystempreserveproductstatus?Isthesystemusedtostoreandpreservethestatus(e.g.,preservetemperature,humidity,etc.)ofinterimandfinalproductorproductsample?系統(tǒng)用于保持產(chǎn)品狀態(tài)嗎？

該系統(tǒng)是否用于儲存和保持中間體、成品或產(chǎn)品的樣品的狀態(tài)（如，

保持溫度、濕度，等）？?

直接影響性評估Doesthesystemproducedatathatisusedtoacceptorrejectproduct?系統(tǒng)是否產(chǎn)生用于接收或拒絕產(chǎn)品的數(shù)據(jù)？Isthesystemaprocesscontrolsystemthataffectsaproduct’ssafety,identity,strength,purityorqualityandthereisnosystemforindependentverificationofcontrolsystemperformanceinplace?該系統(tǒng)是否影響到產(chǎn)品安全、特性、濃度、純度或安全的工藝控制系統(tǒng)，且沒有一個對該控制系統(tǒng)性能進行獨立確認的系統(tǒng)？Isthesystemusedtomanufactureorevaluatetosupportproductdispositionandregulatoryfillings?該系統(tǒng)是否用于生產(chǎn)或評估，以支持產(chǎn)品處置和藥政報批？Doesthesystemcontrol,monitor,oralarmcriticalenvironmentalconditions?該系統(tǒng)是否用于重要環(huán)境條件的控制、監(jiān)測或報警？ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統(tǒng)影響性評估和風險分類審計Systemsimpactcategories1.1

系統(tǒng)的影響類別?ImpactAssessment?

影響評估?Direct

Impact

Assessment?

直接影響性評估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.直接影響系統(tǒng)：預計對“產(chǎn)品”有直接影響的系統(tǒng)，影響到重要房間或功能間的環(huán)境條件，及對GMP

體系的完整性有影響的系統(tǒng)。這些系統(tǒng)的設計和調(diào)試符合GEP。另外，對直接影響系統(tǒng)需要進行確認活動。ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)Validation

Following

Steps驗證后續(xù)步驟Approve&FileDefineRequirements說明要求FinalReport

批準并將總結(jié)報告歸檔High/MidRisk

高／中風險PrepareDevelopProtocol準備驗證方案RunValidation進行驗證FMEA

/FinalReport準備總結(jié)報告QualityRiskAnalysis失效模式和影響分析(FMEA)/質(zhì)量風險分析ValidationWaiverLowRisk驗證豁免低風險ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統(tǒng)影響性評估和風險分類審計Systemsimpactcategories1.1

系統(tǒng)的影響類別?ImpactAssessment?

影響評估?Direct

Impact

Assessment?

直接影響性評估DirectImpactSystemisthekeyoftheGMP

audit,inspection直接影響系統(tǒng)是GMP審計、核查的重點ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統(tǒng)影響性評估和風險分類審計Systemsimpactcategories1.1

系統(tǒng)的影響類別?Direct

Impact

System?

直接影響系統(tǒng)SIP/CIPSystem在線滅菌/在線清洗系統(tǒng)SIP/CIPDistributionSystem在線滅菌/在線清洗分配系統(tǒng)TankWashControlSystem罐清洗控制系統(tǒng)ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統(tǒng)影響性評估和風險分類審計Systemsimpactcategories1.1

系統(tǒng)的影響類別MANUFACTURINGEQUIPMENT生產(chǎn)設備?Direct

Impact

System?

直接影響系統(tǒng)LabelPrintingMachine標簽印字機Cartoner紙盒包裝機Checkweigher稱重機FFULaminarBoothFFU層流罩MetalDetector金屬檢測器ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統(tǒng)影響性評估和風險分類審計SystemsimpactcategoriesQualityControlequipment–ChemicalLaboratory1.1

系統(tǒng)的影響類別質(zhì)量控制設備

化學試驗室-?Direct

Impact

System?

直接影響系統(tǒng)TitratorwithcompleteKFtitrationmodule滴定儀Particlecounter粒子計數(shù)器Bulkdensitytester堆密度計Eccentricity離心機Climate-cabinet恒溫恒濕箱TOCAnalyzerTOC

分析儀RotaryViscometer旋轉(zhuǎn)粘度計VacuumOven真空干燥箱Muffle馬弗爐Oven干燥箱Microscope顯微鏡ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統(tǒng)影響性評估和風險分類審計Systemsimpactcategories1.1

系統(tǒng)的影響類別-QualityControlequipment–IPC質(zhì)量控制設備

中間過程控制室?Direct

Impact

SystemDisintegrationtester崩解儀Friablilator脆碎度儀?

直接影響系統(tǒng)Hardnesstester硬度計Analyticalbalance分析天平Moisture

Analyzer快速水分測定儀ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統(tǒng)影響性評估和風險分類審計SystemsimpactcategoriesQualityControlequipment–MicrobiologicalLaboratory1.1

系統(tǒng)的影響類別

質(zhì)量控制設備–微生物試驗室?Direct

Impact

System?

直接影響系統(tǒng)Balance天平Autoclave高壓滅菌鍋Laminarflowblend凈化工作臺Microbiologicalsafetycabinet生物安全柜Hotairsterilizer熱風滅菌器Water

bath水浴Microscope顯微鏡Incubator培養(yǎng)箱ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統(tǒng)影響性評估和風險分類審計ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統(tǒng)影響性評估和風險分類審計ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統(tǒng)影響性評估和風險分類審計ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統(tǒng)影響性評估和風險分類審計ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統(tǒng)影響性評估和風險分類審計ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統(tǒng)影響性評估和風險分類審計ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統(tǒng)影響性評估和風險分類審計ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統(tǒng)影響性評估和風險分類審計ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統(tǒng)影響性評估和風險分類審計?Assignmentoftheinspectionrating?

檢查評定–Theoverallinspectionratingassignedisbasedontheriskinvolvedtakingintoaccountthenatureandextentofthedeviationswiththecategoryofproductsevaluated.–

綜合評定基于存在的風險，缺陷的性質(zhì)與程度以及評估產(chǎn)品的類別。ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統(tǒng)影響性評估和風險分類審計Risk1(Critical)Observations1類風險（嚴重）缺陷ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統(tǒng)影響性評估和風險分類審計Risk1(Critical)Observations1類風險（嚴重）缺陷?DirectImpactSystem?

直接影響系統(tǒng)?Equipment?

設備–-Equipmentusedforcomplexmanufacturingoperationsofcriticalproductsnotqualifiedandwithevidenceofmalfunctioning.–

用于最高風險產(chǎn)品復雜生產(chǎn)過程的設備不符合規(guī)定，同時存在不能保證生產(chǎn)現(xiàn)象。ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統(tǒng)影響性評估和風險分類審計Risk2(Major)ObservationsApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統(tǒng)影響性評估和風險分類審計Risk2(Major)Observations2類風險（主要）缺陷ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統(tǒng)影響性評估和風險分類審計Risk2(Major)Observations2類風險（主要）缺陷ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統(tǒng)影響性評估和風險分類審計2類風險（主要）缺陷DirectImpactSystem直接影響系統(tǒng)ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統(tǒng)影響性評估和風險分類審計Risk2(Major)Observations2類風險（主要）缺陷ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統(tǒng)影響性評估和風險分類審計Risk2(Major)Observations2類風險（主要）缺陷DirectImpactSystem直接影響系統(tǒng)ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationauditent

System1.基于風險的系統(tǒng)影響性評估和風險分類審計設施和設備系統(tǒng)DirectImpactSystem直接影響系統(tǒng)?

Facilities設施Majorconsiderationswhenevaluatingasepticprocessingoperations…對無菌工藝操作評估需要重要考慮的因素…?

Building

Management

System

(BMS)建筑管理系統(tǒng)（BMS）?

EnvironmentalControls(Temp,RH,DP)環(huán)境控制（溫度、濕度、壓差）?

Qualification

of

System

系統(tǒng)確認?

Maintenance/Calibration

of

system

and

sensors系統(tǒng)和傳感器的維護/校準ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationauditent

System1.基于風險的系統(tǒng)影響性評估和風險分類審計設施和設備系統(tǒng)DirectImpactSystem直接影響系統(tǒng)?

Equipment設備–

Qualification

確認?

Initial

初始確認?

Re-evaluation

--

after

changes

再確認-變更發(fā)生后*(Change

Control

Documentation)

*(變更控制文件)–

Preventive

Maintenance

/

Calibration預防性維護/校準?

SOP

dictates

schedule

or

software

programSOP規(guī)程或軟件程序ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationauditent

System1.基于風險的系統(tǒng)影響性評估和風險分類審計設施和設備系統(tǒng)DirectImpactSystem直接影響系統(tǒng)?

Equipment設備–

Cleaning

Validation

清潔驗證?

Establishing

Limits建立限度?

Recovery

Studies回收率研究?

Executed

Protocol執(zhí)行方案Quality

systems

to

support質(zhì)量系統(tǒng)的支持DirectImpactSystem直接影響系統(tǒng)?

Changemanagement?

ChangerequestsincludingRiskAssessment?

變更管理?

包括風險評估的變更申請?

變更之后的流程，平面圖和文?

Changedprocess,layouts件anddocumentation?

Qualification/Validation?

Validation

Plan?

URS?

確認/驗證?

驗證計劃?

用戶需求標準?

IQ/OQ?

安裝確認/運行確認?

靜態(tài)環(huán)境驗證/環(huán)境監(jiān)測?

培養(yǎng)基灌裝試驗?

PQforEnvironment/Environmentalmonitoring?

PST?

DeviationManagement?

QualityRiskAssessment?

偏差管理?

質(zhì)量風險評估ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)RiskBasedApproachofGMPAuditsFundamentalsofHVAC2.基于風險的空氣凈化系統(tǒng)GMP審計基本原則關鍵組件分析確定審計重點CriticalComponent

Assessment(CCA)todeterminetheauditfocusComponentCriticality

Assessment:

Thecomponentcriticalityassessmentisusedtoassesstherisksassociatedtothecriticalcomponentsofdirectimpactsystemstodeterminetheirrisklevelsintheentiresystemandtoproposecontrolmeasurestoreducetheserisks.部件關鍵性評估(CCA)：通過對“直接影響系統(tǒng)”的關鍵性部件進行風險評估，確定其在整個系統(tǒng)中的風險程度，并建議控制措施降低其風險。ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)RiskBasedApproachofGMPAuditsFundamentalsofHVAC2.基于風險的空氣凈化系統(tǒng)GMP審計基本原則關鍵組件分析確定審計重點CriticalComponent

Assessment(CCA)todeterminetheauditfocusAccordingtotheassessment,componentswillbeclassifiedascriticalornotcritical.通過評估,部件都歸類為關鍵和非關鍵兩種.Theclassificationisgoingtobedonebasedonthefollowingquestions.這種歸類將根據(jù)下列問題進行.Iftheansweris“yes”toanyofthe7questions,thecomponentisclassifiedascritical.七個問題中只要有一個問題的答案是“Yes”，就將該部件歸類為關鍵的部件。ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)RiskBasedApproachofGMPAuditsFundamentalsofHVAC2.基于風險的空氣凈化系統(tǒng)GMP審計基本原則關鍵組件分析確定審計重點CriticalComponent

Assessment(CCA)todeterminetheauditfocus?1-部件是否與產(chǎn)品、產(chǎn)品成分或產(chǎn)品內(nèi)包材直接接觸？Doesthecomponenthavedirectcontactwiththeproduct,productingredientsorproductinnerpackaging??2-與產(chǎn)品接觸的設備在清洗或消毒時需要使用溶劑，部件是否與這些溶劑或/和這些溶劑的配料有接觸？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對產(chǎn)品質(zhì)量或功效具有直接的影響？Doesthenormaloperationorcontrolofthecomponenthaveadirecteffectonproductqualityorefficacy??4-部件是否用于獲得，維護或測量/控制可以影響產(chǎn)品質(zhì)量的關鍵工藝參數(shù)，而對控制系統(tǒng)性能無獨立的驗證？Does

thecomponent/function

control

critical

process

elements

that

may

affect

product

quality

without

independentverificationofthecontrolsystemperformance??5-部件的故障或報警是否對產(chǎn)品質(zhì)量或功效具有直接影響？Doesthefailureoralarmofthecomponent/functionhaveadirecteffectonproductqualityorefficacy??6-從部件獲取的信息被記錄為批記錄、批放行數(shù)據(jù)或其它GMP相關文件的一部分？Istheinformationfrom

this

component

recorded

as

part

of

thebatch

record,

lot

release

data,

or

otherGMP

relateddocumentation??7-部件用于創(chuàng)建或保持某種系統(tǒng)的關鍵狀態(tài)？Isthecomponentusedtocreateorpreserveacriticalstatusofsystem?ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)RiskBasedApproachofGMPAuditsFundamentalsofHVAC2.基于風險的空氣凈化系統(tǒng)GMP審計基本原則關鍵組件分析確定審計重點CriticalComponent

Assessment(CCA)todeterminetheauditfocusApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)RiskBasedApproachofGMPAuditsFundamentalsofHVAC2.基于風險的空氣凈化系統(tǒng)GMP審計基本原則關鍵組件分析確定審計重點CriticalComponent

Assessment(CCA)todeterminetheauditfocusApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)RiskBasedApproachofGMPAuditsFundamentalsofHVAC2.基于風險的空氣凈化系統(tǒng)GMP審計基本原則關鍵組件分析確定審計重點CriticalComponent

Assessment(CCA)todeterminetheauditfocusApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)RiskBasedApproachofGMPAuditsFundamentalsofHVAC2.基于風險的空氣凈化系統(tǒng)GMP審計基本原則關鍵組件分析確定審計重點CriticalComponent

Assessment(CCA)todeterminetheauditfocusHVACSystemtodeterminetheauditfocus空調(diào)凈化系統(tǒng)系統(tǒng)審計重點解析案例

空調(diào)凈化系統(tǒng)系統(tǒng)審計重點解析.docAirConditioningAutomaticControlSystemtodeterminetheauditfocus空調(diào)自控系統(tǒng)審計重點解析案例

空調(diào)自控系統(tǒng)審計重點解析.docParticleMonitoring

Systemtodeterminetheauditfocus粒子監(jiān)測系統(tǒng)審計重點解析案例

粒子監(jiān)測系統(tǒng)審計重點解析.docApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)RiskBasedApproachofGMPAuditsFundamentalsof

PurifiedWaterGeneration/DistributionSystem3.基于風險的純化水制備及儲運系統(tǒng)GMP審計基本原則PurifiedWater

Generation/DistributionSystem純化水制備及儲運系統(tǒng)Maincomponents:主要部件：ActivatedCarbonFilter,

Heatexchanger,ReverseOsmosis,EDI.活性炭過濾器，熱交換器，反滲透、EDI。PWS&DSystemRA純化水儲存與分配系統(tǒng)風險分析ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)RiskBasedApproachofGMPAuditsFundamentalsof

PurifiedWaterGeneration/DistributionSystem3.基于風險的純化水制備及儲運系統(tǒng)GMP審計基本原則關鍵組件分析確定審計重點CriticalComponent

Assessment(CCA)todeterminetheauditfocusComponentCriticality

Assessment:

Thecomponentcriticalityassessmentisusedtoassesstherisksassociatedtothecriticalcomponentsofdirectimpactsystemstodeterminetheirrisklevelsintheentiresystemandtoproposecontrolmeasurestoreducetheserisks.部件關鍵性評估(CCA)：通過對“直接影響系統(tǒng)”的關鍵性部件進行風險評估，確定其在整個系統(tǒng)中的風險程度，并建議控制措施降低其風險。ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)RiskBasedApproachofGMPAuditsFundamentalsof

PurifiedWaterGeneration/DistributionSyst3.基于風險的純化水制備及儲運系統(tǒng)GMP審計基本原則關鍵組件分析確定審計重點CriticalComponent

Assessment(CCA)todeterminetheauditfocusPurifiedWater

Generation

Systemtodeterminetheauditfocus純化水制備系統(tǒng)審計重點解析案例

純化水制備系統(tǒng)審計重點解析.doc通過驗證純化水系統(tǒng)的IQ看審計.docPurifiedWater

DistributionSystem

Systemtodeterminetheauditfocus純化水儲運系統(tǒng)審計重點解析案例案例GMP檢查之SOP純化水監(jiān)測.docPurifiedWater

AutomaticControlSystem

todeterminetheauditfocus純化水自動控制系統(tǒng)審計重點解析案例

純化水自動控制系統(tǒng)審計重點解析.docApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)RiskBasedApproachof

GMPAuditsFundamentalsof

WaterforInjection

Generation/DistributionSystem4.基于風險的注射水制備及儲運系統(tǒng)GMP審計基本原則關鍵組件分析確定審計重點CriticalComponent

Assessment(CCA)todeterminetheauditfocusApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)RiskBasedApproachof

GMPAuditsFundamentalsof

WaterforInjection

Generation/DistributionSystem4.基于風險的注射水制備及儲運系統(tǒng)GMP審計基本原則坡度正壓取樣循環(huán)流速正壓液位，聯(lián)機呼吸器，無泄漏噴淋排放溫度坡度排凈空氣隔斷ApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)RiskBasedApproachof

GMPAuditsFundamentalsof

WaterforInjection

Generation/DistributionSystem4.基于風險的注射水制備及儲運系統(tǒng)GMP審計基本原則關鍵組件分析確定審計重點CriticalComponent

Assessment(CCA)todeterminetheauditfocusWater

forInjection

Generation

Systemtodeterminetheauditfocus注射水制備系統(tǒng)審計重點解析案例

注射水制備系統(tǒng)審計重點解析.docWater

forInjectionDistributionSystem

Systemtodeterminetheauditfocu注射水儲運系統(tǒng)審計重點解析案例

注射水儲運系統(tǒng)審計重點解析.docWater

forInjectionAutomaticControlSystem

todeterminetheauditfocus注射水自動控制系統(tǒng)審計重點解析案例

注射水自動控制系統(tǒng)審計重點解析.docApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)RiskBasedApproachof

GMPAuditsFundamentalsof

compressedairsystems5.基于風險的壓縮空氣系統(tǒng)GMP審計基本原則關鍵組件分析確定審計重點CriticalComponent

Assessment(CCA)todeterminetheauditfocuscompressedairsystemstodeterminetheauditfocus壓縮空氣系統(tǒng)審計重點解析--注意通往與產(chǎn)品直接接觸的氣體的除菌過濾情況的審計案例

壓縮空氣系統(tǒng)審計重點解析.docApplyriskmanagementprinciplestoidentifyFacilities,EquipmentandMeasuringDevicesGMPAuditsparameters一、應用風險管理原則來確定設施、設備以及測量裝置的GMP審計參數(shù)RiskBasedApproachof

GMPAuditsFundamentalsof

MeasuringDevices6.基于風險的測量裝置GMP審計基本原則Risk

Based

Approach

of

System

ImpactAssessment

(SIA)

and

Risk

classification基于風險的系統(tǒng)影響性評估和風險分類審計MeasuringDevicestodeterminetheauditfocus測量裝置審計重點解析案例

測量裝置審計重點解析.doc注意直接影響系統(tǒng)和設備儀器的法定效驗周期以及企業(yè)效驗或者周檢計劃的真實性ApplyriskmanagementprinciplestoidentifyDifferenttypesofproductsGMPAuditsparameters(Facilities,EquipmentandMeasuringDevices)二、應用風險管理原則來確定不同產(chǎn)品類型的GMP審計參數(shù)(設施、設備以及測量裝置)RiskBasedApproachofGMPAuditsFundamentalsofTheoralsolidpreparation1.基于風險的口服制劑GMP審計基本原則ApplyriskmanagementprinciplestoidentifyDifferenttypesofproductsGMPAuditsparameters(Facilities,EquipmentandMeasuringDevices)二、應用風險管理原則來確定不同產(chǎn)品類型的GMP審計參數(shù)(設施、設備以及測量裝置)RiskBasedApproachofGMPAuditsFundamentalsofTheoralsolidpreparation1.基于風險的口服制劑GMP審計基本原則ApplyriskmanagementprinciplestoidentifyDifferenttypesofproductsGMPAuditsparameters(Facilities,EquipmentandMeasuringDevices)二、應用風險管理原則來確定不同產(chǎn)品類型的GMP審計參數(shù)(設施、設備以及測量裝置)RiskBasedApproachofGMPAuditsFundamentalsofTheoralsolidpreparation1.基于風險的口服制劑GMP審計基本原則制粒工藝檢查全機械提升式ApplyriskmanagementprinciplestoidentifyDifferenttypesofproductsGMPAuditsparameters(Facilities,EquipmentandMeasuringDevices)二、應用風險管理原則來確定不同產(chǎn)品類型的GMP審計參數(shù)(設施、設備以及測量裝置)RiskBasedApproachofGMPAuditsFundamentalsofTheoralsolidpreparation1.基于風險的口服制劑GMP審計基本原則顆粒劑生產(chǎn)線連線連續(xù)多鍋濕法制粒烘干重點考察此系統(tǒng)的工藝驗證情況ApplyriskmanagementprinciplestoidentifyDifferenttypesofproductsGMPAuditsparameters(Facilities,EquipmentandMeasuringDevices)二、應用風險管理原則來確定不同產(chǎn)品類型的GMP審計參數(shù)(設施、設備以及測量裝置)RiskBasedApproachofGMPAuditsFundamentalsofTheoralsolidpreparation1.基于風險的口服制劑GMP審計基本原則ApplyriskmanagementprinciplestoidentifyDifferenttypesofproductsGMPAuditsparameters(Facilities,EquipmentandMeasuringDevices)二、應用風險管理原則來確定不同產(chǎn)品類型的GMP審計參數(shù)(設施、設備以及測量裝置)RiskBasedApproachofGMPAuditsFundamentalsofTheoralsolidpreparation1.基于風險的口服制劑GMP審計基本原則ApplyriskmanagementprinciplestoidentifyDifferenttypesofproductsGMPAuditsparameters(Facilities,EquipmentandMeasuringDevices)二、應用風險管理原則來確定不同產(chǎn)品類型的GMP審計參數(shù)(設施、設備以及測量裝置)RiskBasedApproachofGMPAuditsFundamentalsofTheoralsolidpreparation1.基于風險的口服制劑GMP審計基本原則ApplyriskmanagementprinciplestoidentifyDifferenttypesofproductsGMPAuditsparameters(Facilities,EquipmentandMeasuringDevices)二、應用風險管理原則來確定不同產(chǎn)品類型的GMP審計參數(shù)(設施、設備以及測量裝置)RiskBasedApproachofGMPAuditsFundamentalsofTheoralsolidpreparation1.基于風險的口服制劑GMP審計基本原則制粒工藝檢查自動化控制

審查其計算機系統(tǒng)是否驗證以及批記錄打印附件與工藝驗證對比ApplyriskmanagementprinciplestoidentifyDifferenttypesofproductsGMPAuditsparameters(Facilities,EquipmentandMeasuringDevices)二、應用風險管理原則來確定不同產(chǎn)品類型的GMP審計參數(shù)(設施、設備以及測量裝置)RiskBasedApproachofGMPAuditsFundamentalsofTheoralsolidpreparation1.基于風險的口服制劑GMP審計基本原則ApplyriskmanagementprinciplestoidentifyDifferenttypesofproductsGMPAuditsparameters(Facilities,EquipmentandMeasuringDevices)二、應用風險管理原則來確定不同產(chǎn)品類型的GMP審計參數(shù)(設施、設備以及測量裝置)RiskBasedApproachofGMPAuditsFundamentalsofTheoralsolidpreparation1.基于風險的口服制劑GMP審計基本原則ApplyriskmanagementprinciplestoidentifyDifferenttypesofproductsGMPAuditsparameters(Facilities,EquipmentandMeasuringDevices)二、應用風險管理原則來確定不同產(chǎn)品類型的GMP