药品生产验证总计划VMP.docx

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