制药验证类项目文档管理规范

***自动化科技有限公司制药验证类项目文档管理规范

Appendix1GenericTemplate:MainTitle

Example

SOPDocumentManagement

制药验证类项目文档管理规范

ManagementofthisDocument

RoleNameSignatureDate

Author

作者

Review

审核

Approvedby

批准

DocumentNo:XXXXXX

W16001-

Project:制药验证类项目Rev.:1.02015-04-20

Filename:制药类项目文档管理规范附件l.docPage1/11

DocumentHistory

VersionDescriptionAuthorDate

1.0ReleaseforSHENLIANLiuBo2015-01-04

TableofContents

1.PURPOSEOFTHESOP4

2.SCOPE4

3.TERMSANDDEFINITIONS/ABBREVIATIONS4

4.RESPONSIBILITIES4

5.IMPLEMENTATION4

5.1.DOCUMENTPREPARATION4

5.1.1DocumentNo4

5.1.2MandatoryElementstobeIncludedinallDocuments6

5.1.3AppendicesandReferencedDocuments6

5.2VERSIONCONTROL6

SR.DOCUMENTRFVIFW9

5.4DOCUMENTAPPROVAL9

5.5DOCUMENTCHANGES9

5.6HANDWRITTENENTRIESINDOCUMENTS9

5.7.1GeneralRequirements9

5.7.2MarkingofTestDocuments10

5.8.1GeneralRequirements10

5.8.2ManagementofDocumentatSite11

5.8.DOCUMENTRECOVERY11

6.MANAGEMENTOFTHESOP11

7.APPENDICESANDREFERENCEDDOCUMENTS11

7.1APPENDICES11

7.2REFERENCEDDOCUMENTS11

typeorBuildingArea,Thisserialnumberhastobechosenbetween001and999).

{ProjectNo}-{Building/Area卜{doc.type卜{three-digitno.}

Example:W15001LZQPP001istheQualifioationandProjectPlanfortheWholePlantforthe

SHENLIANPASProject.

W16001-LZ-FS-001isforfunctionalspecificationforSHENLIANProject.

Table5-1:DocumentNumberAbbreviations

DocumentTypeAbbreviationRemark

QualificationandProjectQPPValidationdocument

Plan

UserRequirementURSValidationdocument

Specification

FunctionSpecificationFSValidationdocument

DesignSpecificationDSValidationdocument

FATTestPlanFATPValidationdocument

FATTestSpecificationFATSValidationdocument

FATTestPlanSATPValidationdocument

FATTestSpecificationSATSValidationdocument

FATTestReportFATRValidationdocument

FATTestReportSATRValidationdocument

InstallationQualificationIQValidationdocument

Protocol

OperationalQualificationOQValidationdocument

Protocol

InstallationQualificationIOPValidationdocument

andOperational

QualificationTestPlan

InstallationQualificationIQRValidationdocument

Protocol

OperationalQualificationOQRValidationdocument

Protocol

RiskAssessmentRAValidationdocument

ChangeControlCCValidationdocument

ConfiguraionCMValidationdocument

Management

DocumentManagementDMValidationdocument

TraceabilityManagementTMValidationdocument

5.1.2MandatoryElementstobeIncludedinall

Documents

DocumentsshouldhaveacontinuouspaQnn,incl.pagenumberandthetotalnumberofpages

oneverypage.

Everydocumentshouldhaveacoverpa*incl,atleasttheBlowingformalaspects:

•DocumentTitle

・DocumentNo.

•Version

•VersionDate

・ProjectName

・DocumentStatus

•Author'sdateandsignature

•Reviewandapprovaldateandsignature

ADocumentHistoryshouldalsobemaintainedforeachdocumentfromtheinitialdraft..A

ducunienlhistoryclidplerbfiouldbeincurpurdledinedcliducunienl,givingdbriefdescriptionof

thechangesatversion,theauthor(s)ofthechanges,thedateofeditingandifappropriatethe

locationwherethesechangesoccurredinthedocument.

EverydocumentshouldhaveaTableofContents.

Agenericdocumenttemplateisincludedin;

Appendix1:Generictextdocumenttemplate

5.1.3AppendicesandReferencedDocuments

ThefollowingaspectsarerequiredforAppendices:

•NumberingofAppendicesinappropriatemannereg“Appendix1"

•ReferencefrombasisdocumenttoAppendixandviceversa

•Autonomouspaging

•NoseparateapprovalofAppendices.Appendiceswillbeapprovedbyapprovalofthebase

document

Whenreferencinganotherdocument,thereferenceshallincludethedocumentname&number.

Theversionnumbershouldnotbementionedinthereference.Allreferencesbydefaultreferto

thelatestapprovedi.e."valid/approvedandreleasedforu$e"versionofthedocument.

Appendicesshouldusedtocontaininformationortemplatesthatcanbeapproved&maintained

withthebasedocument.Documentswhichareinthemselvessubjecttochangemanagementor

regularmaintenanceshallbeissuedwithadistinctdocumentnumber.

AllAppendicesandreferenceddocumentsshouldbelistedattheendofthedocument.

5.2VERSIONCONTROL

Documentsrequiringversioncontrolshalluseversionnumberswithformat;

ISSUE.REVIVION

Where;

ISSUEisanumberfrom0tomindicatingareleaseofanapproveddocumentforuse,and

REVISIONisanumberfrom0tonindicatingrevisionsofaDRAFTdocumentforreview

Documentsshallalsoindicatetheirstatusasfollows;

•DRAFT

・VALID/Approvedandreleasedforuse

•VOID/Withdrawnandreplacedby...

Whenanewdocumentisissued,theauthorassignstheversionnumber0.1anddistributesthis

underthe'DRAFT'statustothereviewteam.Subsequentchanges&reviewsareindicatedby

incrementingtheREVISIONnumbere.g.0.1isincrementedto0.2,untilthedocumentisreadyfor

approval.

Whenconsecutiveamendments&reviewsresultinaconsensusdocument,theISSUEnumberis

incrementedandtheREVISIONnumberbecomes0,e.g.0.2willbecome1.0.Thisdocumentis

approved(signed)andissuedandthestatuschangesfrom'DRAFT'to'VALID/Approvedand

releasedforuse'.OnlydocumentswithISSUEx.Oandstatus'VALID/Approvedandreleasedfor

use'arepermittedtobeusedforexecutionofengineeringv/orks.

Ifthelatestapprovedversionneedstobechanged,theREVISIONnumberisincrementedandthe

statusreturnsbackto'DRAFT'e.g.1.0willbecome1.1.Thedocumentreviewandapproval

processisthenrepeatedasabove.

TheDocumentHistoryshallbemaintainedtodescribethereasonforchanges&changesin

documentstatus.

AProjectDocumentListshallbemaintainedtorecordthecurrentversion&versionhistoryofall

projectdocuments.Thedocumentlistshallrecorddocumentsproducedbytheproject,andalso

designinputdocumentsreceivedfromotherparties.Projectdocumentsarelistedin;W16001LZ

DM002:ProjectDocumentList

Initialnumber

Figure5-1:VersionControl

5.3.DOCUMENTREVIEW

Documentreviewsshallbecarriedoutpriortoformalissueofadocument.

Thereviewcantakeanumberofforms,rangingfromcirculationofthedocumentandcollection

ofcommentsthroughtoformalreviewmeetings.Thereviewersshouldconsistofasaminimum,

thepersonsdecidedbymanagementandidentifiedonthecoverpageofthedocument.

Whereformalreviewmeetingsarearranged,eachsectionofthedocumentshouldbecovered

andminutestaken,Iftherearenocommentsonaparticularsectionthenthisshouldbeindi:ated

intheminutes.

Actionarisingfromthedocumentreviewshouldberesolvedpriortoapprovalandissue.

Responsibilityforthisshouldbedefined,andwillnormcllyrestwiththeauthor.Queriesor

disputesoverrequiredchangesshouldberesolvedwiththereviewteam.Oncetheagreed

changeshavebeenincorporatedthedocumentisreadyforapproval.

5.4DOCUMENTAPPROVAL

Theapproversshouldconsistof,asaminimum,thepersonsdecidedbymanagementand

identifiedonthecoverpageofthedocument.Approvalfromtwoormoreresponsiblepersonsis

normallyrequiredforkeydocuments.

ApproversshallbeidentifiedbyROLEandNAME/ORGANIZATION.

Approversshallsign&datetheapproveddocument.

Modificationstoapproveddocumentsshallbereviewedandapprovedbythesamefunctionsor

organizationsthatperformedtheoriginalreviewandapproval,unlessspecificallydesignated

otherwise.

Oncetheauthororapproverisoutofthedocumentlocation,thescannedversionwiththe

signatureofthepersoncanbeused,Printoutthescannedversionpageandkeepwiththe

originalwetsignaturetogether.

Inthiscase,thedocumentshouldbefirstlyconvertedintoPDFformattobesurewehaveallthe

samedocumentapproved.

5.5DOCUMENTCHANGES

ModificationstoapproveddocumentsshouldonlybeprogressedunderChangeControlin

accordancewithdocument;

W16001-LZ-CC-001:SOPProjectChangeControl

5.6HANDWRITTENENTRIESINDOCUMENTS

5.7.1GeneralRequirements

Handwrittenentriesindocumentsshouldbecarriedoutincompliancewiththefollowing;

•Allentriesshouldbedocumentproof.Entriesmustnotbeerasableandshouldbecopyable.

■Examplesfordocumentproofwritingutensils:ballpointpen,stampingink,

non-erasablemarkerpen.

■Examplesofnotdocumentproofwritingutensils:pencil,erasableink.

•Handwrittenentriesshouldnotbecarriedoutinblackordarkcolourink.Blueorredcolour

ispreferablemakingitreadilyidentifiableasamarkup.

•Handwrittenentriesshallbelegible,writteninblockletters.

•Allentriesshouldbecarriedoutdirectlyontheediteddocument.

•Handwrittenmarkupsshallclearlyidentifywhat,when,whyandwhohasmadethe

markup.

■Erasingentriesbycorrection-fluid,e.g.Tipp-ExorBlancoRollerisnotpermitted.

Correctionsshouldbecarriedoutbycrossingthemistakewithonesinglelinesothe

historyisstillvisible.Nexttothecorrectiontheexecutorhastosign/initialanddate.

■Nexttoeverynotself-explanatorycorrectionasnortnoteshouldbewrittendownto

explain,whythecorrectionhasbeencarriedout,e.g.'typingerror','correction

of...,/correctionduetoChangeControlNo.

•Handwrittenentriesorcorrectionsinalreadyapprovedandinusedocumentsisnot

permittedexceptwhen;

■Allpersonnelresponsibleforapprovalarecarr/ingoutthecorrection(signingthe

entry).

■Allpersonnelresponsibleforapprovalrepeattheapprovalafterthecorrectionhas

beencarriedout.

■Wheretheentryisrequiredtocompletethedocument,asintestresultsdocuments.

•DateformatsignedbyhandwritingshouldbeDD-MMM-YYYYforEnglish

DocumentorYYYY-MM-DDforChineseDocument.With;

■DD:daynumberwithinthemonthi.e.1-31

■MMM:monthwrittenwith3characteri.e.JAN,FEB,MAR,APR,MAYJUN,

JULZ...

■YYYY:yearnumberi.e.2015

5.7.2MarkingofTestDocuments

5.8.1GeneralRequirements

Documentationandassociatedinformationshouldbestoredsafelyandsecurely.Theyshould

beprotectedagainstaccidentalandmaliciousdamage,andshouldberetrievablethroughoutthe

definedretentionperiod.Hardcopiesofprojectdocumentsshallbestoredinasecurelocation

(e.9.acupboardwithalock).Supersededandobsoleteversionsofdocumentsshallbestored

separatelyfromthelatestapprovedversions.

Appropriatehardcopyfiling&softcopyfolderstructuresshallbeestablishedtosuittheproject

needs.Thisshallhaveasminimumsubfoldersforeachtypeofdocuments:

・Current

•History

Table5-2:Projectarrangements:

DocumentTypeHardCopyStorageLocationSoftCopyStorageLocation

Currentmasterdocument,ProjectFile:CurrentProjectServer

includingapprovalsignatures・Documentwithwet•Scannedcopiesofdocs

signatureswithwetsignatures

Originalelectronicformat(e.g.n/aProject\\Current

MSWord,Exceletc.)and

associatedPDFversion

Superseded,withdrawn,andProjectFile:HistoryProjct\\History

obsoleteversionsofcontrolled

projectdocuments

5.8.2ManagementofDocumentatSite

Theoriginalwetsigneddocumentshouldbemaintainedonsiteandasthe"MASTERCOPY'.For

thoselivedocumente.g.parametersheet,whichwillbechangedandupdatedfrequency,these

documentshallbestamped'MASTERCOPY'InredInk&placedInfileslocatedsuch

thattheyareavailabletobemarkedupduringthetesting&commissioningphaseson

site.Mark-upsshallbeperformedtoidentifyallchangesallowingthedocumentstobeAs-built

aftercommissioning.

5.8.DOCUMENTRECOVERY

Signedoffdocumentsneedtobescannedandstoredinanappropriatelocationassoonas

possible.Thescannedversionofasignedoffdocumentcanreplacetheoriginaldocumentonceit

hasbeenestablishedthatithasbeenlost.

6.MANAGEMENTOFTHESOP

ThisSOPisexclusivelymanagedbytheValidationManagerofthisproject,ordelegatedtothe

ValidationEngineer.

7.A