药品生产验证总计划VMP.docx
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药品生产验证总计划VMP.docx
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药品生产验证总计划VMP
PharmacyManufacturingUnitValidationMasterPlan(VPM).
GeneralNotes
AimsofQualificationandValidation
Anysignificantchangesto,premises,equipmentorprocesses,whichmayaffectthequalityofthefinalproduct,directlyorindirectly,shouldbequalifiedandvalidated.
ThekeyelementsofaqualificationandvalidationprogramshouldbeclearlydefinedanddocumentedinaValidationMasterPlan.Theprocessshouldestablishandprovidedocumentaryevidencethat:
premises,supportingutilities,equipmentandprocesseshavebeendesignedinaccordancewiththerequirementsofGMP.ThisnormallyconstitutestheDesignQualificationor‘DQ’andincludesconfirmationthatthepremises,supportingutilitiesandequipmenthavebeenbuiltandinstalledincompliancewiththeirdesignspecifications(thisconstitutesInstallationQualificationor‘IQ’)andthattheyoperateinaccordancewiththeirdesignspecifications(thisconstitutesOperationalQualificationorOQ).
Aspecificprocesswillconsistentlyproduceaproductmeetingitspredeterminedspecificationsandqualityattributes(thisconstitutesProcessValidationorPV.ThetermPerformanceQualificationorPQmaybeusedalso).
Purpose
TheVMPisintendedtobea‘live’documentthatsupportsthedesignandconstructionofanyproductionfacility,itssubsequentoperation,maintenanceandchangestothefacilityforitslifespan.TheVMPshouldpresentanoverviewoftheentirevalidationoperation,itsorganisationalstructure,itscontentandplanning.ThecoreoftheVMPisthelist/inventoryofitemstobevalidatedandtheplanningschedule.
TheVMPshouldprovideyourorganisationwiththebasisforvalidationandqualitysystemactivitiesrequiredforcGMPcompliance.Thiswillenableanysterileornon-sterilemedicinalproductthatisproduced,processed,storedordistributed,bythemanufacturingunit,tobevalidatedunderthecontrolofanappropriatequalitysystem.
TheVMPshouldprovideacross-referencetootherdocuments,suchasSOP’s,validationprotocols,validationreports,anddesignplans.Arationalefortheinclusionorexclusionofvalidations,fromtheapproachadoptedshouldbeincluded.
VMPDocument
TheVMPtemplateisattachedforcompletionasappropriatethedocumentshouldbecross-referencedwithdesignspecifications,designplansandotherrelevantdocumentation.AppendicesshouldcontainalltherelevantdocumentationreferencedorstatedintheVMP.
CompanyLogo
CompanyName
VALIDATIONMASTERPLAN
DocumentReference:
ReferenceNumber
Revision:
DraftNumberorRevisionNumber
DateofIssue:
____/____/____
Page:
2of___
Approvedby:
Name:
Signature:
Date:
ProductionTeamLeader
QualityControlOfficer
SeniorEngineer
Compiledby
Title:
Name:
Signature:
Date:
ValidationEngineer
CONTENTS
1.0LISTOFABBREVIATIONS5
2.0DocumentRevisionHistory6
3.0ValidationSteeringCommittee7
3.1MembershipofValidationSteeringCommittee7
3.2Responsibilities8
3.2.1PharmacyProductionTeamLeader8
3.2.2PharmacySeniorProductionTechnician8
3.2.3TrustSeniorEngineer8
3.2.4PharmacyQualityControlOfficer8
3.2.5ValidationEngineer8
4.0Introduction9
4.1PurposesofVMP9
4.2OverviewofProject9
4.3ValidationPhilosophy9
5.0RegulatoryStandardsAndGuidelines10
6.0DescriptionofProductsandProcesses11
6.1Introduction11
6.2ProductGroups11
6.3Processes11
6.4ProductStorageandDistribution11
7.0PROJECTDESCRIPTION12
7.1SiteLocation12
7.2FacilityDesignandLayout.12
7.3ProductionSuites12
7.3.1Zone1,Non-SterileManufacturing12
7.3.2Zone2,PreparationofCytotoxicProductsandParentalNutritionProducts12
8.0EquipmentandservicestobeValidated14
8.1ImpactAssessment14
8.2RiskAssessment14
8.3ValidationMatrix14
9.0ValidationActivities15
9.1ValidationActivities15
9.1.1UserRequirementSpecification(URS)15
9.1.2TechnicalSpecification15
9.1.3ImpactAssessment15
9.1.4DesignReview/Qualification15
9.1.5FactoryAcceptanceTests15
9.1.6Commissioning16
9.1.7InstallationQualification16
9.1.8Calibration16
9.1.9OperationalQualification17
9.1.10StandardOperatingProcedures17
9.1.11PerformanceQualification18
9.1.12CombinedQualifications(I/OQ&O/PQ)18
9.1.13ProcessValidation(PV)18
9.1.14CleaningValidation18
9.1.15AnalyticalMethodandLaboratoryEquipmentValidation19
9.1.16ProductStorageandDistributionValidation19
9.1.17RelocatedEquipment19
9.1.18ComputerValidationTesting20
9.1.19ComputerOperationalQualification错误!
未定义书签。
9.2ValidationReports20
9.3ValidationHistoryFile20
10.0CHANGECONTROL21
10.1VMPRevisions21
10.2ChangeControlInitiation21
10.3DefinitionofChange21
10.4ChangeControlProcedure21
11.0QUALITYMANAGEMENT22
12.0SCHEDULEOFSTANDARDOPERATINGPROCEDURES23
13.0PREVENTATIVEMAINTENANCE24
14.0SCHEDULEOFWORKPACKAGES25
15.0TRAINING26
16.0ResponsibilitiesandAPPROVALOFProtocolsandDOCUMENTATION27
16.1ProtocolResponsibility27
16.2ApprovalofProtocolsandReports27
16.3ApprovalOfValidationDocumentation27
Appendices
Annex1Cleaningvalidationmasterplan
Annex2Analyticalmethodvalidationmasterplan
1.0LISTOFABBREVIATIONS
AHU
AirHandlingUnit
NHS
NationalHealthService
BP
BritishPharmacopoeia
O&M
OperationandMaintenance
BS
BritishStandard
OQ
OperationalQualification
CFR
CodeofFederalRegulations
P&ID
PipingandInstrumentationDiagram
cGMP
CurrentGoodManufacturingPractice
PCA
PatientControlledAnalgesia
CIP
CleanInPlace
PFD
ProcessFlowDiagram
CIVA
CentralisedIntravenousAdditives
PID
ProportionalIntegralandDerivative
Comm.
Commissioning
plc
Programmablelogiccontroller
CPU
CentralProcessingUnit
PQ
PerformanceQualification
DC
DirectCurrent
PV
ProcessValidation
DCC
DesignChangeControl
QA
QualityAssurance
DQ
DesignQualification
QC
QualityControl
DR
DesignReview
QMS
QualityManagementSystem
EDR
EnhancedDesignReview
RA
RiskAssessment
EP
EuropeanPharmacopoeia
Rev.
Revision
EU
EuropeanUnion
SAT
SiteAcceptanceTest
FAT
FactoryAcceptanceTest
SIP
Sterilise/SanitiseInPlace
FDA
FoodandDrugAdministration
SOP
StandardOperatingProcedure
FDS
Functional;DesignStatement
SVA
SmallVolumeAmpoules
GA
GeneralArrangement
TPN
TotalParenteralNutrition
GAMP
GoodAutomatedManufacturingPractice
URS
UserRequirementStatement
GCP
GoodCleaningPractice
VCC
ValidationChangeControl
GEP
GoodEngineeringPractice
VMP
ValidationMasterPlan
GLP
GoodLaboratoryPractice
VSC
ValidationSteeringCommittee
HACCP
HazardAndCriticalControlPoint
VTF
ValidationTechnicalFile
HS&E
HealthSafetyAndEnvironment
WFI
WaterForInjection
HTM
HealthTechnicalMemorandum
HVAC
Heating,VentilationandAirConditioning
IA
ImpactAssessment
IQ
InstallationQualification
ISO
InternationalStandardsOrganisation
ISPE
InternationalSocietyofPharmaceuticalEngineers
LVF
LargeVolumeFluids
MCA
MedicinesControlAgency
2.0DocumentRevisionHistory
Revision
Details
Date
Author
Draft1
Initialdraft
__/__/__
Draft2
__/__/__
Draft3
__/__/__
Revision00
Originalissue.
__/__/__
Revision01
__/__/__
3.0ValidationSteeringCommittee
3.1MembershipofValidationSteeringCommittee
ThisValidationMasterPlanhasbeencompiledbyaValidationSteeringCommittee(VSC)whowillalsomanageitsexecution.ThemembersoftheVSCarelistedbelowandbytheirsignaturesacknowledgetheirresponsibilitiestoensurethatallvalidationactivitiesarecarriedoutasdescribedinthisValidationMasterPlan(VMP)anditsannexes.
ItisrecommendedthatthemembersoftheVSCshouldinclude,butisnotlimitedtothefollowingareasofresponsibilityandexpertise:
▪PharmacyProductionTeamLeader
▪PharmacySeniorProductionTechnician
▪TrustSeniorEngineer
▪PharmacyQualityControlOfficer
▪cGMPConsultant
▪ValidationSpecialist
Additionalmembersco-optedontotheVSCshallalsosignbelowbeforeundertakinganyactivitiesassociatedwiththisVMP.
Name(Print)
Position/Company
Initial
Signature
Date
3.2
Responsibilities
WithrespecttotheactivitiesoutlinedinthisVMPanditsAnnexes,includingcleaning,manufacturingpracticesandanalyticalmethods,theresponsibilitiesofkeyVSCmembersareoutlinedbelow.Theirresponsibilitieswithrespecttotheoveralloperationareincludedwherethismayhaveanimpactuponvalidationactivities.
Approvalofneworamendeddocumentationshouldbeaccomplishedwiththeminimumofdelay,ideallywithin2workingdays,tofacilitatetheefficientoperationofthefacility
3.2.1PharmacyProductionTeamLeader
Thepharmacyproductionteamleaderisresponsiblefor:
▪Ensuringthatappropriatelyqualifiedpersonnelareappointed.
▪EnsuringproductionprocessesareinaccordancewithcGMPrequirements.
▪Facilitatingvalidationactivities.
▪Trainingandmanagementofpersonnel.
▪Approvalofuserfunctionalaspectsofvalidationprotocols
▪Approvalofworkingproductiondocumentsforoverallcontent.
3.2.2PharmacySeniorProductionTechnician
Thepharmacyoperationsrepresentativeisresponsiblefor
▪Completionofbatchrecords.
▪Operatingprocedures.
▪Trainingofpersonnel.
3.2.3TrustSeniorEngineer
▪Ensuringthatsystems/equipmentareappropriatefortheirpurpose.
▪Maintenanceofsystems/equipment.
▪Maintenanceprocedures.
▪Calibrationpolicyandproc
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