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審計參數一RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統影響性評估和風險分類審計RiskBasedApproachofGMPAuditsFundamentalsofHVAC2.基于風險的空氣凈化系統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GMP審計基本原則RiskBasedApproachof

GMPAuditsFundamentalsof

compressedairsystems5.基于風險的壓縮空氣系統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品類型的GMP審計參數(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.標準操作規程CalibrationProgram2.校準計劃PreventativeMaintenance3.預防性維護EnvironmentalMonitoring4.環境監測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RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統影響性評估和風險分類審計Systemsimpactcategories1.1系統的影響類別directimpactsystem直接影響設備系統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RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統影響性評估和風險分類審計Systemsimpactcategories1.1

系統的影響類別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RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統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?在生產關鍵步驟時或之后，系統和產品（例如輔料、原料、溶劑、或加工材料）有直接接觸？1.1

系統的影響類別?ImpactAssessment?

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

Impact

AssessmenDoesthesystempreserveproductstatus?Isthesystemusedtostoreandpreservethestatus(e.g.,preservetemperature,humidity,etc.)ofinterimandfinalproductorproductsample?系統用于保持產品狀態嗎？

該系統是否用于儲存和保持中間體、成品或產品的樣品的狀態（如，

保持溫度、濕度，等）？?

直接影響性評估Doesthesystemproducedatathatisusedtoacceptorrejectproduct?系統是否產生用于接收或拒絕產品的數據？Isthesystemaprocesscontrolsystemthataffectsaproduct’ssafety,identity,strength,purityorqualityandthereisnosystemforindependentverificationofcontrolsystemperformanceinplace?該系統是否影響到產品安全、特性、濃度、純度或安全的工藝控制系統，且沒有一個對該控制系統性能進行獨立確認的系統？Isthesystemusedtomanufactureorevaluatetosupportproductdispositionandregulatoryfillings?該系統是否用于生產或評估，以支持產品處置和藥政報批？Doesthesystemcontrol,monitor,oralarmcriticalenvironmentalconditions?該系統是否用于重要環境條件的控制、監測或報警？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RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統影響性評估和風險分類審計Systemsimpactcategories1.1

系統的影響類別?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：預計對“產品”有直接影響的系統，影響到重要房間或功能間的環境條件，及對GMP

體系的完整性有影響的系統。這些系統的設計和調試符合GEP。另外，對直接影響系統需要進行確認活動。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Validation

Following

Steps驗證后續步驟Approve&FileDefineRequirements說明要求FinalReport

批準并將總結報告歸檔High/MidRisk

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

/FinalReport準備總結報告QualityRiskAnalysis失效模式和影響分析(FMEA)/質量風險分析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RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統影響性評估和風險分類審計Systemsimpactcategories1.1

系統的影響類別?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RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統影響性評估和風險分類審計Systemsimpactcategories1.1

系統的影響類別?Direct

Impact

System?

直接影響系統SIP/CIPSystem在線滅菌/在線清洗系統SIP/CIPDistributionSystem在線滅菌/在線清洗分配系統TankWashControlSystem罐清洗控制系統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RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統影響性評估和風險分類審計Systemsimpactcategories1.1

系統的影響類別MANUFACTURINGEQUIPMENT生產設備?Direct

Impact

System?

直接影響系統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RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統影響性評估和風險分類審計SystemsimpactcategoriesQualityControlequipment–ChemicalLaboratory1.1

系統的影響類別質量控制設備

化學試驗室-?Direct

Impact

System?

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

分析儀RotaryViscometer旋轉粘度計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RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統影響性評估和風險分類審計Systemsimpactcategories1.1

系統的影響類別-QualityControlequipment–IPC質量控制設備

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RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統影響性評估和風險分類審計SystemsimpactcategoriesQualityControlequipment–MicrobiologicalLaboratory1.1

系統的影響類別

質量控制設備–微生物試驗室?Direct

Impact

System?

直接影響系統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RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統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RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統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RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統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RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統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RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統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RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統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RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統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RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統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RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統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，缺陷的性質與程度以及評估產品的類別。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RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統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RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統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?Equipment?

設備–-Equipmentusedforcomplexmanufacturingoperationsofcriticalproductsnotqualifiedandwithevidenceofmalfunctioning.–

用于最高風險產品復雜生產過程的設備不符合規定，同時存在不能保證生產現象。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RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統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RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統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RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統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RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統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RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統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RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationaudit1.基于風險的系統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RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationauditent

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

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（BMS）?

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

Qualification

of

System

系統確認?

Maintenance/Calibration

of

system

and

sensors系統和傳感器的維護/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RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationauditent

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

Equipment設備–

Qualification

確認?

Initial

初始確認?

Re-evaluation

--

after

changes

再確認-變更發生后*(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RiskBasedApproachofSystemImpactAssessment(SIA)andRiskclassificationauditent

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

Equipment設備–

Cleaning

Validation

清潔驗證?

Establishing

Limits建立限度?

Recovery

Studies回收率研究?

Executed

Protocol執行方案Quality

systems

to

support質量系統的支持DirectImpactSystem直接影響系統?

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?

靜態環境驗證/環境監測?

培養基灌裝試驗?

PQforEnvironment/Environmentalmonitoring?

PST?

DeviationManagement?

QualityRiskAssessment?

偏差管理?

質量風險評估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RiskBasedApproachofGMPAuditsFundamentalsofHVAC2.基于風險的空氣凈化系統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”的關鍵性部件進行風險評估，確定其在整個系統中的風險程度，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RiskBasedApproachofGMPAuditsFundamentalsofHVAC2.基于風險的空氣凈化系統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RiskBasedApproachofGMPAuditsFundamentalsofHVAC2.基于風險的空氣凈化系統GMP審計基本原則關鍵組件分析確定審計重點CriticalComponent

Assessment(CCA)todeterminetheauditfocus?1-部件是否與產品、產品成分或產品內包材直接接觸？Doesthecomponenthavedirectcontactwiththeproduct,productingredientsorproductinnerpackaging??2-與產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品質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/控制可以影響產品質量的關鍵工藝參數，而對控制系統性能無獨立的驗證？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品質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、批放行數據或其它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-部件用于創建或保持某種系統的關鍵狀態？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RiskBasedApproachofGMPAuditsFundamentalsofHVAC2.基于風險的空氣凈化系統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RiskBasedApproachofGMPAuditsFundamentalsofHVAC2.基于風險的空氣凈化系統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RiskBasedApproachofGMPAuditsFundamentalsofHVAC2.基于風險的空氣凈化系統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RiskBasedApproachofGMPAuditsFundamentalsofHVAC2.基于風險的空氣凈化系統GMP審計基本原則關鍵組件分析確定審計重點CriticalComponent

Assessment(CCA)todeterminetheauditfocusHVACSystemtodeterminetheauditfocus空調凈化系統系統審計重點解析案例

空調凈化系統系統審計重點解析.docAirConditioningAutomaticControlSystemtodeterminetheauditfocus空調自控系統審計重點解析案例

空調自控系統審計重點解析.docParticleMonitoring

Systemtodeterminetheauditfocus粒子監測系統審計重點解析案例

粒子監測系統審計重點解析.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RiskBasedApproachofGMPAuditsFundamentalsof

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

Generation/DistributionSystem純化水制備及儲運系統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RiskBasedApproachofGMPAuditsFundamentalsof

PurifiedWaterGeneration/DistributionSystem3.基于風險的純化水制備及儲運系統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”的關鍵性部件進行風險評估，確定其在整個系統中的風險程度，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RiskBasedApproachofGMPAuditsFundamentalsof

PurifiedWaterGeneration/DistributionSyst3.基于風險的純化水制備及儲運系統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純化水制備系統審計重點解析案例

純化水制備系統審計重點解析.doc通過驗證純化水系統的IQ看審計.docPurifiedWater

DistributionSystem

Systemtodeterminetheauditfocus純化水儲運系統審計重點解析案例案例GMP檢查之SOP純化水監測.docPurifiedWater

AutomaticControlSystem

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

純化水自動控制系統審計重點解析.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RiskBasedApproachof

GMPAuditsFundamentalsof

WaterforInjection

Generation/DistributionSystem4.基于風險的注射水制備及儲運系統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RiskBasedApproachof

GMPAuditsFundamentalsof

WaterforInjection

Generation/DistributionSystem4.基于風險的注射水制備及儲運系統GMP審計基本原則坡度正壓取樣循環流速正壓液位，聯機呼吸器，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RiskBasedApproachof

GMPAuditsFundamentalsof

WaterforInjection

Generation/DistributionSystem4.基于風險的注射水制備及儲運系統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注射水制備系統審計重點解析案例

注射水制備系統審計重點解析.docWater

forInjectionDistributionSystem

Systemtodeterminetheauditfocu注射水儲運系統審計重點解析案例

注射水儲運系統審計重點解析.docWater

forInjectionAutomaticControlSystem

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

注射水自動控制系統審計重點解析.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RiskBasedApproachof

GMPAuditsFundamentalsof

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

Assessment(CCA)todeterminetheauditfocuscompressedairsystemstodeterminetheauditfocus壓縮空氣系統審計重點解析--注意通往與產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注意直接影響系統和設備儀器的法定效驗周期以及企業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品類型的GMP審計參數(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品類型的GMP審計參數(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品類型的GMP審計參數(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品類型的GMP審計參數(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線連線連續多鍋濕法制粒烘干重點考察此系統的工藝驗證情況ApplyriskmanagementprinciplestoidentifyDifferenttypesofproductsGMPAuditsparameters(Facilities,EquipmentandMeasuringDevices)二、應用風險管理原則來確定不同產品類型的GMP審計參數(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品類型的GMP審計參數(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品類型的GMP審計參數(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品類型的GMP審計參數(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品類型的GMP審計參數(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品類型的GMP審計參數(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品類型的GMP