GAMP5及計(jì)算機(jī)化系統(tǒng)驗(yàn)證相關(guān)知識(shí)課件

GAMP5(GoodAutomated

Manufacturing

Practice)良好自化生踐指南ARiskBasedApproachtoCompliantGxPComputerisedSystem遵從GxP算

機(jī)

化

系

管的管理方法.hGkAMP5及算機(jī)化系相關(guān)知DifferentTerminology不同的?

Computerised

Systems算機(jī)系A(chǔ)utomation

Systems自化系ControlSystems控制系????ControlEquipment控制DataManagement

systems數(shù)據(jù)管理系Computerised

System:Asystemincludingtheinputofdata,electronicprocessingandtheoutputofinformation

tobeusedeitherforreportingorautomaticcontrol算機(jī)系:系中包括數(shù)據(jù)入，子化理和用于告或自控的信息出SFDA:GoodManufacturingPractice

forpharmaceutical

products(Draftforcomment)SFDA：品生量管理范（征求意.hkIntroduce介GAMP5（

GoodAutomated

Manufacturing

Practice

-Rev5）GAMP是由國制工程會(huì)（ISPE）主的踐指南。自

90年代以來，不斷改版的良好自化生踐指南被廣泛使用并得到國管部的公。它是算機(jī)化系的

指

方

。

GAMP5是GAMP的第5版本。算機(jī)化系由

硬

件

、

件

、

網(wǎng)

件和可控的功能和相關(guān)文件成操作程與人硬件固件受控的功能與流程控制系算機(jī)化系.hkIndustryRegulators行

管機(jī)構(gòu)-Regulatetoensuresafetyofdrugsthatanyofusmighttake!-通管理保我任何人都可能用到的品的安全-Allhavethepowertorefuseimportsiftheirregulationsarenotmet.-如不符合管理定，任何人都有拒。MHRASFDA(Chinese(Medicines

and

Healthcare

Products

RegulatoryAgency

‐

was

previously

the

MCA)

（品及保健品管理局‐前身督局）FDA中國的FDA)EMEA(European

MedicinesEvaluation

Agency‐includes

MHRA

andequivalents

from

otherEU

countries)(歐洲品管理局‐包括MHRA

英國管局和其它歐盟國家的等機(jī)構(gòu))HC‐SC(Health

Canada

–Sante

Canada)加拿大生部NIHS(National

Institute

of

HealthScience)（國立境健康科學(xué)研究院）FDA(Food

and

DrugAdministration)食品與物督管理局TGAMCC

(MedicineControl

Council)品控制委會(huì)(Therapeutic

GoodsAdministration)治

品管理局.hkUSFDA?

Automated

processes.

Whencomputers

orautomateddataprocessing

systems

areusedaspartofproductionorthequality

system,

themanufacturer

shallvalidatecomputer

softwareforitsintendeduseaccording

toanestablished

protocol.Allsoftwarechangesshallbevalidated

beforeapprovalandissuance.

Thesevalidationactivities

andresultsshallbedocumented.自化程。當(dāng)算機(jī)或自數(shù)據(jù)理系做生或量系的一部分，制造商需要算機(jī)件系是按照先使用的。所有件更在準(zhǔn)使用前是可的。些的活和果被文檔PART

820QUALITYSYSTEMREGULATION量系第

820部分.hkEMEA?

Validation:Theextentofvalidation

necessarywilldependonanumberoffactorsincludingtheusetowhichthesystemistobeput,whetherthevalidation

istobeprospectiveorretrospective

andwhetherornotnovelelements

areincorporated.

Validation

shouldbeconsideredaspartofthecompletelifecycleofacomputersystem.Thiscycleincludesthestagesofplanning,specification,programming,testing,

commissioning,

documentation,

operation,monitoringandmodifying.：的范基于一包含用于系的因素，無是性的是回性的，無有無新元素的使用。算機(jī)系完整生命周期的部分。個(gè)周期包括范，程，，文檔，運(yùn)行，控

和

修

改

。Commission

Directive3003/94/ECAnnex

11Computerised

system3003/94/EC附11算機(jī)系.hkSFDA?

Whereautomated

andmonitoringsystemsareusedfortheseapplications

theyshouldbevalidated

toensurethatcritical

processrequirements

aremet.使用自化和的地方，以確保足關(guān)程要求GoodManufacturingPracticeforpharmaceutical

products,PartIIAnnex(DraftforComment)Chapter12TerminalSterilisation:品生量管理范第二部分附（征求意稿）第

12章最.hkAddition充第110條（第1次的是115條款）：使用算機(jī)化管理的，有相的操作程防止因系故障、停機(jī)等特殊情況而造成物料和品的混淆和差。第164條（第1次的是172條款）：如使用子數(shù)據(jù)理系、照相技或其它可靠方式數(shù)據(jù)料，有所用系的程；的準(zhǔn)確性核。如果使用子數(shù)據(jù)理系，有受人方可通算機(jī)入或更改數(shù)據(jù)，更改和除情況有使用密或其它方式來限制數(shù)據(jù)系的登；

關(guān)數(shù)

據(jù)

入后

，由

人

獨(dú)立行復(fù)核。用子方法保存的批采用磁、微卷、副本或其它方法行

份

，

以

確

保

的安全，且數(shù)據(jù)料

在

保

存期內(nèi)便于來源：sFDA品

生

量管理范第2次

2009.12.10.hkPurpose目的?

Costeffective

frameworkofgoodpractice

toensurethatcomputerised

systems

arefitfortheintended

useandcompliant

applicable

regulations良好踐的有效架構(gòu)以保算機(jī)系是足使用要求和章要求的?

Safeguard:Patient

safety,productsquality,

&dataintegrity保條款：患者安全，品量和數(shù)據(jù)完整?

Providesuppliersguidanceonthedevelopment

andmaintenance

ofthesystemsbyfollowinggoodpractice.通良好踐，供商提供系開和的指.hkKeyConcepts.hk關(guān)概念.hkGAMP5KEYCONCEPTS

1-product/Process

UnderstandingGAMP5關(guān)概-

/工的理解‐

fundamental

to

determining

system

requirements.決定系要求非常重要‐

basis

for

making

risk‐based

decisions.是

根

據(jù)

作出決定的基End

user

SHOULD

do

the

following:最用a)

Identify

Critical

Quality

Attributes

(CQAs)

for

their

product

during

drugdevelopment.

在

開

程中確定其品

的

關(guān)

量屬性Critical

Quality

Attributes

for

a

Tablet?片的關(guān)量屬性？purity,

potency,

stability…度、效價(jià)、定性

…….b)

Classify

CQAs

in

terms

of

their

effect

on

patient

safety.根據(jù)其患者安全的影響關(guān)量屬性行分Impact

on

Patient

Safety?患者安全的影響？purity,

potency,

stability

all

high

impact度、效價(jià)、定性都具有很高的影響.hkGAMP5KEYCONCEPTS

1-product/Process

UnderstandingGAMP5關(guān)概-

/工的理解End

user

SHOULD

do

the

following:最用c)

Identify

material

attributes

and

process

parameters

which

might

affect

any

of

theCQAs

確定能任何關(guān)量屬性生影響的的物料屬性和工參數(shù)e.g.

Material

Attributes

/

Process

Parameters

affectingPURITY?

例如，能影響度的物料屬性

/工參數(shù)purity

of

the

input

materials;

temperature

of

processing;ambient

humidity/temperature;

cleanliness

of

equipment…原材料的度；工溫度；境溫濕度；d)

Investigate

the

design

space

for

each

attribute

/

parameter

in

order

torate

their

criticality.每屬性

/參

數(shù)

的

行研究以判定其關(guān)性e.g.

How

much

can

ambient

humidity

/

temperature

vary

without

affectingthe

tablet

stability?例如，在不影響片定性的情況下境溫濕度的允化范是多？.hkGAMP5KEYCONCEPTS1-product/ProcessUnderstanding

GAMP5

關(guān)概-

/工的理解End

user

SHOULD

do

the

following:最用e)

Used

that

information

to

propose

a

control

strategy

for

theprocess.

通

種信息來提出工的

控

制

策

略

。e.g.

Control

Strategy

for

Ambient

T

/

RH?

例如，境溫濕度的控制策略？f)

Create

a

URS

splitting

that

control

strategy

into

individualfunctions

(related

to

CPPs

and

classified

according

to

their

impact).寫URS，將種控制策略分配到獨(dú)的控制功能中（與工參數(shù)相關(guān)并根據(jù)其影響行分）。.hkGAMP5KEYCONCEPTS

2-LifecycleapproachwithinaQMSGAMP5關(guān)概2-量管理系內(nèi)的生命周期法Planningcover:劃包含activities,

Responsibility,

procedures&timelines活，任，流程和Specification:范enablesystemtobedeveloped,verified&Maintained.Itmaybesuppliedbyasupplier使系可以被開.可由供商提供VerificationNormalcase(+vetesting),Invalidcase(-vetesting),Repeatability,Performance,

Volume/load,Regression,Structuraltesting常，非法，重復(fù)，性能，，不，構(gòu)性Validation

report:告Summerising

activities

performed,deviations,

outstandingandcorrectiveactions行的活，偏差，和作正.hkGAMP5KEYCONCEPTS

2-LifecycleapproachwithinaQMSGAMP5關(guān)概2-量管理系內(nèi)的生命周期法Life

cycle

activities

should

be

scaled

according

to:從如下方面生命周期活價(jià)：a)

system

impact

on

patient

safety,

product

quality

and

data

integrity

系患者安全、品量和數(shù)據(jù)完整性的影響。e.g.

Rank

these

control

systems

in

terms

of

impact:例如，根據(jù)其影響性如下控制系行排序：2Tablet

manufacturing

system片生系Water

for

injection

sterilisation

system

1注射用水菌系Building

management

system樓宇控制系4

(indirect

impact

only)接影響Waste

treatment

system理系5

(no

impact)無影響Ointment

mixing

vessel膏混合罐3.hkGAMP5KEYCONCEPTS

3-ScalableLifeCycleActivitiesGAMP5關(guān)概3-可增減生命周期活Life

cycle

activities

should

be

scaled

according

to:從如下方面生命周期活價(jià)：b)

system

complexity

and

novelty

系的復(fù)性和新性e.g.

Rank

these

software

modules

in

terms

of

the

intrinsic

risk

they

posedue

to

complexity

/

novelty:

例如，根據(jù)因復(fù)性

/新性而具有的內(nèi)在如下件模行排序：?Underlying

operating

system

and

networkinfrastructure

操作系和網(wǎng)基架構(gòu)GAMP

Category

1

第1?Standard

package

such

as

SiemenWinCC

如西

GAMP

Category

3

第3子WinCC等準(zhǔn)包GAMP

Category

3

第3GAMP

Category

4

第4?Firmware

such

as

PLC

如PLC等固件?Configured

element

such

as

function

Blocks如功能等配置元件?Bespoke

coded

sequence,

ladder

logic,

C++protocol

conversion,

etc

定

制

序列、梯形、

C++GAMP

Category

5

第5.hkGAMP5KEYCONCEPTS

4-ScienceBased

QualityRiskManagementGAMP5關(guān)概4-根據(jù)科學(xué)行的量管理“Application

of

Quality

Risk

Management

enables

effort

to

be

focused

on

criticalaspects

of

a

computerized

system,

in

a

controlled

and

justified

manner”行量管理使我能以受控且可以的方式將工作重點(diǎn)集中在算機(jī)系的關(guān)域。行初步分析并確定系的影響確定患者安全、品量和數(shù)據(jù)完整性具有影響的功能行功能分析并確定控制方法行并適宜的控制方法并控控制效果.hkGAMP5KEYCONCEPTS

4-ScienceBased

QualityRiskManagementGAMP5關(guān)概4-根據(jù)科學(xué)行的量管理“Regulated

companies

should

seek

to

maximise

supplier

involvement

throughoutthe

system

life

cycle

in

order

to

leverage

knowledge,

experience

and

documentation,subject

to

satisfactory

supplier

assessment

”

“在行了很好的供商估之后，符合管要求的公司在系的整個(gè)生命周期內(nèi)盡量利用供商的參與以充分利用其

知

、和文件。

”What

does

Austar

have

to

offer?

奧星所能提供有：Knowledge:知：Experience:process

control

expertise工控制有技validating

control

systems

to

GAMP根據(jù)GAMP控制系：Documentation:comprehensive

template

documents文件合模版文件‐

planning劃‐

specification范‐

verification

確‐

reporting告.hkKeyPersonnel關(guān)人?

Process

Owner:Thepersonultimately

responsibleforthebusinessprocessorprocessesbeingmanaged程所有者：最生或被管理的程而的人?

SystemOwner:Thepersonultimately

responsiblefortheavailability

,support,andmaintenanceofasystemandforthesecurityofthedataresidingonthatsystem系所有者：系的可用性，支持和，及系上數(shù)據(jù)安全性而的人?

SubjectMatterExpert:Thoseindividuals

withspecificexpertiseinaparticular

areaorfield.SMEshouldtaketheleadroleintheverification

ofcomputerised

systems.SMEresponsibilities

includeplanninganddefiningverification

strategies,

definingacceptancecriteria,

selection

ofappropriatetestmethods,execution

ofverification

testsandreviewingresults家：在某一域有某特定技的人。

SME算機(jī)系的

SME任包括劃和定策略，定準(zhǔn)，適的方法，行核果.hkBusiness

Benefit

益Benefitstobothregulatedcompanies&supplier:公司和供商均得到的益?

Reduction

ofcost&timetakentoachieveandmaintaincompliance降

低

一致性的用

和?

Earlydefectidentification

andresolution:reducecost,speed早期的辨和解決：降低用，提高度?

Costeffectiveoperationandmaintenance高效運(yùn)行和?

Effective

changemanagementandcontinuousimprovement有效的更管理和持性改?

Providingframeworkforuser/supplierco-operation/供商作提供架?

Assistingsupplierstoproducerequireddocs助供商生要求文檔?

Promotionofcommonlifecycle,language,andterminology建立常用生命周期，言和?

Providingpracticalguidesandexamples提供用的指南和例子.hkSupportingProcesses支持程?

Risk

Management管理?

Change&Configuration

Management更和管理?

DesignReview?

Traceability追溯性?

DocumentManagement文檔管理.hkComputerised

SystemLifeCycle.hk算機(jī)系生命周期.hkProjectStages.hk段.hkRegulatedCompanyActivities公司活?

IdentifyCompliance

standardsbasedoncompanyprocedure基于公司流程辨出一致性準(zhǔn)?

GxPAssessmentGxP估?

IdentifyKeyIndividuals:ProcessOwner,SystemOwner,QualityUnit,SME,Supplier,EndUser人?

ProduceUserrequirement

Specification寫URS?

DetermineStrategyforAchievingcompliance:

RiskAssessment,AssessmentofSystemcomponent,Supplierassessment決定達(dá)成一致的策略：估，系估，供商估?

Plan

劃?

ReviewandApproveSpecifications核和批準(zhǔn)范?

Developteststrategy開策略?

Test?

Report&release告和布?

Maintain

systemcomplianceduringOpeartion運(yùn)行系一致性?

Retirement退役.hkSupplier

activities供商活?

Establish

QMS:Documented

setofprocedures&standards建立量管理系：一流程和準(zhǔn)文檔?

Establish

Requirement

(whatenduserwants)建立需求(最用需要什么

)?

Qualityplanning量劃?

Assessmentofsub-supplier分包商估?

Producespecifications寫范?

Performdesignreview行核?

Hardware&Softwareproduction/configuration硬件生及?

Performtesting行?

Commercial

releaseofthesystem系?

Provideuserrequirement

andtraining提供用需求和培?

Supportandmaintainthesysteminoperation運(yùn)行中，支持和系?

SystemRetirement

andreplacement系退役和取代.hkV-model生命周期和文件架構(gòu)IFIT’SNOTDOCUMENTEDIT’SARUMOUR!如

果

沒

有

被

下來，一切都是流言！.hk算機(jī)系的

施用需求明URSVP用需求明屬于客方文件。文件中列出了客在本目系方面的所有要求。它是寫功能明（FS）的基劃是一份描述了整個(gè)目的體策略的文件并列出了客的管和量要求。量和目

劃量和目劃界定了奧星足客的需求在行目程中所采取的量措施。另外它列出了目的果和目劃工作。QPP目范內(nèi)將包括一個(gè)估的程。此估程界定出了用于控制GMP要求或客有影響的的必要措施。必確定出些其行估、文件。最后，必界定出降低些所必行的措施并其行追蹤。RA更控制所有能影響已批準(zhǔn)的文件的系更均需根據(jù)更控制程來行控制。了保可以明所有些更均符合劃、估、批準(zhǔn)、并根據(jù)符合

GMP的形式得以施并通文件方式行

了

，將寫

一

份

目

SOP來界定控制更所需行的工作。ChangeControl.hk算機(jī)系的

施功能明功能明（FS）中描述了如何來需求明（

URS）中所述的要求和目。本文件FSDS明確明了期系的方式。

FS由目行方寫，由客是否有與

URS中所述要求有沖突之及是否確能此要求。

FS必由客來批準(zhǔn)。批準(zhǔn)之后，F(xiàn)S即作客和目行方在及管理本目方面具有束力的明以更的

方

式

明

了

如何來在系中

各種功能。其中涉

及

到

硬

件明又涉及到件

明

。確從管的角度來看以及了控制，必相關(guān)的要求行。整在不同的行劃、施和告，各段在本

QPP中做出了明。在確劃中定出了工作的適宜步。確劃必考客一般情況及確工作的要求，其是在URS及劃中所定的要求。此外，估的范及方面均具有一定的影響。QP偏差管理此程保所有偏差均必和控制，直至它得以正。在確劃中此程行了描述。DeviationManagement.hk算機(jī)系的

施工廠收工廠收在系施完成之后在系供商的地行。工廠收完成之后客FAT同意系。行盡的工廠收的另一個(gè)點(diǎn)在于能盡早地件程中所存在的，以在客安裝系之前將其正?？?工廠收行。-安裝確了明系根據(jù)定行了安裝、能在其運(yùn)行境下正常工作、且與表及的界面符合定

。

因

的重點(diǎn)在于安裝及功能方面，所以一

步被劃分SAT-IQ和SAT-OQ。SAT-IQ是了明系被正確地在客的目境中行了安裝。SAT-IQ-運(yùn)行確SAT-OQ屬于收的一部分，它是了明系能在其運(yùn)行境下正常運(yùn)行，且其與表和的界面符合定。SAT-OQ安裝確與SAT-IQ相比，IQ由客來行。必要明系根據(jù)技行了正確的安裝（硬件和件）。除了SAT-IQ中

已

行的之外，

IQ中需要包括一些由客所增加的IQ。.hk算機(jī)系的

施運(yùn)行確與SAT-OQ相比，OQ由客來行。必要明系具有符合技明的正確功能。除了SAT-OQ中

已

行的之外，

OQ中需要包括一些由客所增加的，在盡可能接近生工境條件下行的功能OQ確確出了各一段的果，并告所出的重大或微偏差是否已清除。本告中包括所有段是否充分完成以及系是否得以確的QRVR出了一目段的整個(gè)果，并明了整體最果。此文件必以客任方行寫?？勺匪菥馗鶕?jù)GAMP5，建立以文件形式要求與明和成分之的可追溯性、以及些成分與相之的可追溯性的流程。TM所有要求都必在明文件及中得以考，不能有任何漏?？勺匪菪跃乜蓭椭吭谡麄€(gè)目程中所有與要求相關(guān)的目。它可以在目生命周期中雙向并追蹤要求的理情況。.hkAnyquestion?.hkGAMP5Software&Hardware

Categories件和硬件.hkGAMP5

HardwareCategories

硬件CategoryTypicalApproach典型方法1,StandardHardwareComponents準(zhǔn)硬件部件?Documentmanufacturerorsupplierdetail,serialnumberandversionnumber?通文件下生廠家或供商的情、序列號(hào)和版本號(hào)?Correctinstallationtobeverified?確正確的安裝?ConfigurationManagementandChangecontrolapply?適用配置管理和更控制2,CustomBuiltHardwareComponentsAsperaboveplus:上述內(nèi)容再加上：定制制造的硬件部件

?Designspecification?明?Acceptancetesting?收?ConfigurationandChangecontrolapply?適用配置和更控制.hkGAMP5

SoftwareCategories件Category

Description明Typicalexamples典型示例TypicalApproach典型方法1,?Layeredsoftware分式件?SoftwareusedtoRecordversionnumber,verifycorrectinstallationbyfollowingapprovedinstallationprocedure版本號(hào)，按照所批準(zhǔn)的安裝程正確的安裝方式。InfrastructureSoftware基件?Operatingsystems操作系?Databaseengines數(shù)據(jù)引擎?Middleware中件?Programminglanguages程言?Spreadsheets子制表件?Versioncontroltools版本控制你工具managetheoperatingenvironment用于管理操作境的件?Networkmonitoringtools網(wǎng)控工具3,Non-configured非配置

件?Runtimeparametersmaybeenteredandstored,butthesoftwarecannotbeconfiguredtosuitthebusinessprocess?可以入并存運(yùn)行參數(shù)，但是并不能件行配置以適合流程?Firmwarebasedapplications基于固件的用程序?COTssoftwareCOTS件?AbbreviatedLifecycleapproach?化的生命周期法?URS用需求明?Riskbasedapproachtosupplierassesment?基于的供商估方?Recordversionnumber,verifycorrectinstallation?版本號(hào)，正確的安裝方式?Riskbasedtest基于行?Procedureinplaceformaintainingcompliance有用于持系符合性的程.hkGAMP5

SoftwareCategories件4,?Life

cycle

approach生命周期法?BMS?HMI?LIMS?ERP?Record

version

number,

verify

correctinstallation版本號(hào)，正確的安裝方式?Risk

based

testing

in

a

test

environment在境中根據(jù)行?Risk

based

testing

within

the

businessprocess在

流程中根據(jù)行?Procedure

in

place

for

maintainingcompliance具有持符合性的程件通常非常復(fù)，可以由用來行配置以足用具體流程的特殊要求。種件的

不能更改。Software定制customdesigned

andcoded

to

suitexternally

developed?More

rigorous

supplier

assessment,

withpossible

supplier

audit更格的公用施估，包括可能行供商IT

applications.內(nèi)部和外部開的IT用程序theprocess.hkbusiness?Possession

of

full

life

cycle

完整的生命周.hk.hk.hkGAMP5Planning

Phase劃段URS用需求明.hkUserRequirement

Specification用需求明?

Mostimportantdocument最重要的文件?

Describes

whatthesystemissupposedtodo描述系期用途?

NormallywrittenbytheSupplier通常由供商寫?

Controlled

Document受控文件?

ForCat3writtenforaspecificsolution第3具體解決方案寫?

ForCat4&5Itiswritteningeneral第4、5整體寫?

Sufficient,

Realistic,

Measurable,

Achievable充

分

、

、可衡量、可達(dá)到?

Testable:Clear,

Precise,

basisforformaltesting可量：清楚、正式的基?

Traceable:

Designand

testing可追溯：?

Definepriority:Mandatory,Beneficial,

Nicetohave定先：必、有益、有了更好.hkURS-Content

用需求明

-內(nèi)容?

Introduction:

介–Whoproducedthedocument文件寫人–Contractual

status合同狀–Relationship

tootherdocument與其它文件關(guān)系?

Overview:

Backgroundtotheproject概述：目背景?

Scope:范–Systemboundaries系范–Keyobjective

andbenefits關(guān)目和益–Applicable

GXPrequirement適用GXP要求–Otherapplicable

regulations

其它適用法.hkURS-Content:Operational

RequirementURS-內(nèi)容：操作要求?

Functions功能–Whatisthesystemrequiretodo系要求的功能–Calculations算–Modesofoperation(UseCases)

操作模式（使用示例）–Alarms警–FailureModes故障模式–Safety安全–Electronics

Records,

AuditTrail,&ElectronicsSignature子

跟蹤、子

名–Reports,

datafiles,

etc告、數(shù)據(jù)文件等.hkURS-Content:Operational

RequirementURS-內(nèi)容：操作要求?

Data數(shù)據(jù)–

Datahandlingrequirement(Paper,Electronics)

數(shù)據(jù)理要求（物理版、子版）–

Dataimpact數(shù)據(jù)影響–

Definition

ofdata:format,critical

parameters,datarangelimits,requiredaccuracy,

etc

數(shù)據(jù)的定：格式、關(guān)參數(shù)、數(shù)據(jù)范、所要求準(zhǔn)確性等–

Electronics

Records,AuditTrail,&Electronics

Signature子蹤、子名–

Reports,datafiles,etc告、數(shù)據(jù)文件等–

Datamigration數(shù)據(jù)遷移–

Datainputandsubsequentediting數(shù)據(jù)入及之后的–

Backup&recovery份和恢復(fù)–

Archiverequirement存檔要求–

DataSecurityandintegrity數(shù)據(jù)安全和完整性.hkURS-Content:Operational

RequirementURS-內(nèi)容：操作要求?

Technicalrequirement技要求–

Startup,shutdown,Coldstart,Warmstart,Hotstart啟、停機(jī)、冷起、暖起、起–

Disaster

recovery災(zāi)恢復(fù)–

Performanceandtimingrequirement性能和要求–

ActiononComponentfailure部件故障的措施–

Hardwarerequirement

硬件要求–

Portability

便攜性–

Efficiency

效率–

Configurability可配置性.hkURS-Content:OperationalRequirementURS-內(nèi)容：操作要求?

Interfaces

界面–

I/Olisting–

I/O列表–

Interfacetoothersystems/equipment–

與其它系/界面–

HMI–

Usersgroupsandtheiraccess

rights–

用

及其限–

Networkprotocolssupported:serial,OPC,Profibus–

所支持網(wǎng)：序列、

OPC、

Profibus?

Environment境?

Physicalcondition:Temp,Humidity,Hazardous?

物理境：溫度、濕度、危害?

Physicalspaceandlimitations?

物理空和局限公用工程?

Utilities.hkURS-ContentURS-內(nèi)容：?

Constraints

限制條件–

Availability

(redundancy?)&reliability–

可用性（冗余？）和可靠性–

Expansioncapability–展容量–

Futureexpansion–

未來展–

Expected

lifetime–期使用壽命–

Longtermsupport–期支持.hkURS-ContentURS-內(nèi)容：?

LifeCyclerequirement生命周期要求–

Development

requirement:GAMP

5–

開要求：GAMP5–

SupplierQualityrequirement–

供商量要求–

Documentation

requirement文件要求––

TestingRequirement:Internaltesting,FAT,SAT–要求：內(nèi)部

FAT、SAT–

Training–

培–

Supportandmaintenanceservice–

支持和服–

Spares–件.hkAnyquestion?.hkGAMP5

PlanningPhaseGAMP5劃段QualityandProjectPlan量及目

劃.hkQualityPlan量劃?

AQualityPlanisakeydocumentindefiningtheprojectlifecycle.

Itsetsouttheproposedmethodofmeeting

theuserqualityrequirements

andallowsagreement

ofthecontrolling

proceduresforeachprojectactivity.?量劃是一個(gè)關(guān)文件，它界定了目的生命周期。定出了了足用量要求所提采取的方法，使各目工作符合控制程的要求。?

QualityPlanistheresponsibilityofthesupplier?量劃屬于供商的任?

Itshouldnormallybesuppliedwithinthefirstweekofsigningcontract.?

一

般

需

在

合同之后一周內(nèi)提供?

ItiswritteninresponsetoValidation

Plan?作劃的響而寫?

ItneedstobeapprovedbyUser.?

需要由用來批準(zhǔn)?

Generally

onceapprovedshouldnotrequirefurtherrevision.?

一般批準(zhǔn)之后不需再行修.hkQP-Contents

QP-內(nèi)容?

Relationship

tootherDocuments

與其它文件關(guān)系–

Applicable

standard適用準(zhǔn)–

Relationship

tocustomer

Validation

Requirements

與客要求之關(guān)系–

Non-ConformancewithUserRequirement與用需求的不符合–

Relationship

t?

Projectoverview目概述–

SummaryofProcesstobecontrolled

所需控制工概述–

Relevant

GxPregulations

相關(guān)GxP法–

ImpactonPatient

Safety,ProductQuality,

dataintegrity患者安全、品量和數(shù)據(jù)完整性的影響–

Projectboundariesandinterfaces

(scopeofsupplyandvalidation目范和接口（供范和–

SystemArchitecture

系–

Systemclassification:

Hardwareandsoftwarecategories

系分：硬件和件.hkQP-Contents

QP-內(nèi)容?

ProjectLifeCyclephases目生命周期段–

ItshouldfollowGAMP5LifeCyclemodel遵循GAMP5所定生命周期模型–

Listwhatactivities

willbeperformed列出所需行工作–

Defineswhowillberesponsibleforexecuting

eachactivity

確定行每工作的–

Thelevelofactivitydependsonthedegreeofnovelty工作的內(nèi)容取決于新性程度確–

Dependingonthesizeandcomplexity,

somedocumentsmaybemergedintoasingleone

根據(jù)模和復(fù)性，有些文件可以合一個(gè)文件配置和–

Documentscreatedneedtobereviewedandapprovedbyenduser所寫文件需要由最用核批準(zhǔn)包

括

管理在內(nèi)的支持性流程.hkQP-Contents–ProjectLifeCycleQP-內(nèi)容-目生命周期?PlanningPhase劃段–Review

ofURS–核URS–Creation

ofProject

scheduleandapproval–制并批準(zhǔn)目度–Creation

ofQuality

Planandapproval–寫和批準(zhǔn)量劃.hkQP-Contents–ProjectLifeCycleQP-內(nèi)容-目生命周期?

Specification

Phase技段–

Creation

ofFunctional

DesignandApproval–寫并批準(zhǔn)功能明–

Creation

ofHardwareDesignincludingDrawingsandapproval–寫并批準(zhǔn)硬件明，包括–

RiskAssessment–估–

Creation

ofSoftwareDesignandapproval–寫并批準(zhǔn)件明–

Creation

ofSoftwareModuledesignandapproval–寫并批準(zhǔn)件模.hkScalability

ofActivities工作的可放大性Non-configuredsoftwareelement不可配置件可配置件件件Bespokesoftwareelement定制件件Infrastructuresoftwareelement基件件LifecyclePhase生命周期段ConfiguredsoftwareelementFunctionalSpecification(mayalsodetaildesignandconfigurationonasimple/lowrisksystem)功能明（于/低

也

可

描述和配置情況）HardwareDesignandConfigurationSpecificationifjustifiedbyHIGH/MEDIUMriskpriorityorbythecomplexityofthehardware如根據(jù)高/中先或硬件的復(fù)性判定需要，寫硬件明和配置明SoftwareDesignandConfigurationSpecificationifjustifiedbyHIGH/MEDIUMriskpriorityorbythecomplexityofthesoftware如根據(jù)高/中先件的復(fù)性判定需要，寫件明和配置明SoftwareModuleSpecificationifjustifiedbyHIGH/MEDIUMriskpriorityorbythecomplexityofthesoftware如根據(jù)高/中

先

或硬件的復(fù)性判定需要，寫件模Forallcategoriesofsoftware,settingsandparameterswhicharecriticaltomeetinguserrequirementsaredetailedwithinthedocumentation.Allothersettingsandparametersarecontrolledelectronicallyviabaselinesofthesoftwaretakenpriortoeachverificationphaseandatprojecthandover.The‘a(chǎn)shandedover’settingsandparametersaresuppliedtotheenduserwithinthesoftwarebaselineonCD/DVD.Subsequentmodificationsmadeon-linearecontrolledviatheaudittrail.Subsequentmodificationsmadeoff-linearecontrolledviatheconfigurationmanagementsystemandresultinanewbaselinebeingtaken.所有件，在文件中明符合用需求所需的關(guān)定和參數(shù)。所有其它定和參數(shù)均根據(jù)在每之前及目移交所件基情況通子方式行控制。將

“移交”定和參數(shù)和件基情況交CD/DVD上.hk付最用。隨后的任何在更改均通跟蹤行控制。隨后的任何離更改均通配置管理系行控制并形成QP-Contents–ProjectLifeCycleQP-內(nèi)容-目生命周期?

Configuration

andCodingPhase配置和段–

OrderHardware–硬件–

BuildSystem–

構(gòu)建系–

Developsoftware–

開–

Produceconfiguration

scheduleandConfiguration

management–

制定

配置劃

表和配置管理–

Integratethesystem–

集成系.hkQP-Contents–ProjectLifeCycleQP-內(nèi)容-目生命周期?

Verification

Phase段–

SoftwareCodeReview件代回–

CreateSoftwareModuleTestProtocolandapprove–寫并批準(zhǔn)件模方案–

CreateFactoryAcceptance

Testspec

Protocolandapprove(hardwareandSoftware)–寫并批準(zhǔn)工廠收程和方案（硬件和件）–

CreateSiteAcceptance

TestProtocolandapprove–寫并批準(zhǔn)收方案–

ExecuteInternalSoftwareModuleTestandreviewresult–行內(nèi)部件模并果–

ExecuteInternalFATtestandreviewresult–行內(nèi)部FAT果–

Executewitnessed

FATtestandreviewresult–行并FAT果–

Shiptosite運(yùn)至–

Installandcommission

安裝–

ExecuteSite

Acceptance

TestandReviewresult–行收果.hkQP-Contents–ProjectLifeCycleQP-內(nèi)容-目生命周期?

ReportingPhase告段–

Generatesystemfinaldocumentation,

review&approve–

生成系最文件并行批–

Ensureallthedesigndocumentsare“asBuilt”version–

保

所有文件均“竣工”版本–

Createtechnicalmanual寫技手冊(cè)–

ProvideTrainingforOperators,engineers,

etc–操作人、工程等行培–

GenerateFinalQualityreportandHandoverchecklist,

reviewandapprove–

生成最告和移交表并行–

Complete

handover完成移交.hkQP-ContentsQP-內(nèi)容?SupportingActivities

支持性工作–Traceability

可追溯性–ChangeManagement更管理–Configuration

Management

配置管理?

Itemstobecontrolled

所需控制目?

Versioncontrol

版本控制–Documentation

Management

文件管理?

Versioncontrol版本控制?

Documentstobeprovidedandformat

所需提供文件及其格式.hkQP-ContentsQP-內(nèi)容?Project

Planning目劃–Projectteamandits

organisation–目及其–ProjectprogressreportingGlory

He–目程告Matt

SafiQualitEylaMinaenWagaenrg(QM)Quality

Assurance

(QA)Project

Manager

(PM)(nominated

primary

contact)(responsible

for

validation)Validation

consultant–ProjectMilestones–目里程碑Glory

HeLead

Engineer

(LE)Software

Engineer(s)Alice

LvDrawing

Office

(DO)Ivan

GaoHardware

EngineersIvan

GaoAlice

Lv.hkAnyquestion?.hkGAMP5Planning

PhaseRiskAssessmentGAMP5劃段.hkRiskAssessment估?

IdentifyCriticalQualityAttributes(CQAs)forproductduringdrugdevelopment.

Theseareattributeslikepurity,potency,stability

whichareintrinsictotheproduct.在品開程中確定關(guān)量屬性（

CQA）。例如品而言非常重要的度、效價(jià)、定性。?

Classify

theseCQAsintermsoftheireffectonpatientsafety根據(jù)關(guān)量屬性患者安全性的影響其分。?

Identifymaterial

attributesandprocessparameterswhichmightaffectanyoftheCQAs(egpuritymightbeaffectedby:purityoftheinputmaterials;

temperature

ofprocessing;cleanlinessofequipment…).確定可能會(huì)影響任何關(guān)量屬性（例如度可能會(huì)受入原

料

的

度

、

工

溫

度

、

度等影響）的材料屬性和工參

數(shù)?

IdentifytheDesignSpaceforthosematerial

attributes

andprocessparameters(iedetermine

howtheycanvarywhilststillgivinggoodqualityproduct)inordertodeterminewhichareCritical

Material

AttributesorCriticalProcessParameters(CPPs)andtogiveeachanimpactrating確定些物料屬性和工參數(shù)的（即確定在保良好品量的同其所允的化范）以確定哪些是關(guān)量屬性或關(guān)工參數(shù)并其行影響性定?

Usethatinformation

toproposeacontrolstrategyfortheprocesswhichwillguaranteeoperationwithinthedesignspaceandalsoguaranteethatanynecessarydatatoprovethisiscollected.

使用信息將保操作在范內(nèi)并保收集了明一點(diǎn)的數(shù)據(jù)的流程而提出的控制策略?CreateaURSwhichsplitsthecontrolstrategyintoindividualfunctions(related

tocriticalprocessparameters)

andclassified

accordingtotheirimpactonproductquality/patientsafety/dataintegrity.制URS將控制策略分各獨(dú)的功能（與關(guān)工參數(shù)相關(guān)）并根據(jù)其量

/患者安全性/數(shù)據(jù)完整性的影響將其分。.hkRiskAssessment估?

RiskAssessmentreportdetails

theriskassessmentandm