manual是什么

什么是sop（WhatisSOP）

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WhatistheSOP?-standardoperatingprocedures(SOP)

operationprocedures2009-09-3015:21standardbasicknowledge

(SOP)isanimportantpartofallkindsofstandardization

managementcertificationandproductcertification,the

theSOP?Simply

speaking,SOPisamanualoperationofthecoverandcontain

OPisanecessaryconditiontoensurethe

otonlyatechnical

model,itismoreimportanttocoverthemanagementidea,the

einamatureindustry,have

aclearmanagementstandardsandcertificationsystem,sothe

SOPstandardizationandmaturityarerelativelyhigh,the

e

thereisnolaboratorymanagementandcertificationsystem,the

inspectionworkinthemature,inthepreparationofSOPwill

beblind.

Firstofall,SOPhasthecharacteristicsoftheindustry,

pectionwork,

theinstrumenthasSOPinstrument,reagentreagentSOP,each

projecthasdifferentSOP,nobacteria,biochemicalandimmune

thesubjectsofdifferentSOP,differentprojectswithina

snotatest,andat

of.

Second,SOPunavoidably,thatistosayaslongasassociated

withtheproject,tobedetailedandcomprehensive,toinclude

ilotoperationprocedureas

anexample,thefirstisunexpectedly"sit",thusitcanbeen

operationisnot

simple,butshouldbepracticalandshouldbecomeatoolbook,

lSOPshouldmakeadon't

understandafterlearningcanbecomeanexpert.

Third,SOPisnotonlythedetailedinstructions,itisapart

ofstandardmanagement,alsoincludesqualitycontroland

managementphilosophy,fromwhichcanevenethestaffing

situation.

AlthoughthespecificcontentofdifferentindustriesSOPis

different,butitisreallyalogicalconnection,solearnfrom

otherindustriespeciallysimilarindustrySOPrequirements

maceuticalproductionSOPasan

example,therequirementsofGMPcertificationrequirements,

accordingtoGMP,theSOPkeyisattached.

FromthefocusondrugSOP,SOPtestshouldbeconsidered:

1,operatingproceduresandinstruments:experimental

procedures,experimentalinstrumentsandexperimentalu

afterprocessing,experimentalcleaning,experimentalspills

processingetc.

2,qualitycontrol:qualitymonitoringandexperimental

instruments,suchasthenumberofqualitycontrol(high,

mediumandlow?)Andthecalibrationoftheinstrument

(personnel,time,etc.),maintenanceandmaintenance,the

originalrecordtc..Theoriginalrecordisveryimportant,

animportantmeanstodiscoverandsolveproblems,inaddition

topatientdata,butalsoenvironmentalparameters(weather

conditions,suchastemperatureandhumidity),theuof

instrumentandinstrument,sampleandreagentmanufacturers,

qualitytraitsandbatchnumber,thesamebatchofquality

controlresultsandthetreatmentmethods(suchasreview,

resampling,thereport,asdetailedaspossible).

3,theabnormalresultsofdiagnosisandtreatmentofabnormal

results:judgmentindex,andanalysisreasonsandprocedures

mple,abnormalresults,orexperimentalerrorsor

mistakes?Howtojudge?Whatisthenormalrangeofthesample?

Nonnormalspecimensifprocessing,muchlargerthanorless

thanthenumberofrevieworassociatedwiththeclinic?

4,theprocessshouldinclude:samplereceiving,reportaudit,

qualityproblemsandreceivinginstrumentprocessingmusthave

whoreceivedspecimens,whoreport,

howmuchtime,howmuchtime,towhom,instrumentfailurereport

supportprogrametc..

5,reagentandsamplequalityindicators,acceptanceand

storage:who,whoizedandinwhatwayifthecurityis

storage,:storagerefrigerator

temperaturemonitoringandfailurewarningwhowhoreagentand

standardbacteriaforsolong.

6,staffresponsibilities:personnelresponsibilitiesare

embodiedasintheprocess,suchasinstrumentisbad,report

towhoandwho,whoauditreport,abnormallaboperatorwhat

kindoftreatment,whatshouldbereportedtothecompetentand

soon.

OfcourtherearepersonneltrainingSOPbetter.

SOPcanwriteinspection,operationmanual,instrumentkitfor

Lambon,accordingtotheDepartmentandonthedownstream

content,suchassamplecollectionandhandling,theabnormal

resultsofprocessingcontentcanbeudfortheprojector

jectSOPplussamplecollection,report

issuance,purcha,storageanddeliveryacceptancereagent

SOPwasbasicallycompleted.

Appendix:

ThekeycontentofdrugproductionSOP:

1deviation

Withthatandforpossiblewiththeexpectedresults,

conclusionssuchasbias,andyieldintheexpectedrange,the

productdoesnotcomplywiththespecifications,thereaction

conditionsdonotmeetthespecificparameters,equipment

standardsandsoon,whenandhowtobestudied,whatisthe

programtotakemeasuresandwhetherreasonableetc..

Experimentaldemonstration,scientificexaminationand

approvaletc..

2internalaudit

Asfaraspossibletoclearlydescribehowandwhenandbywhom

theinternalaudit,internalauditandwhy,methodsand

procedurestakenwhatetc..

3externalaudit

Descriptionofthesupplier(rawmaterials,packaging

materialsandotherreasons)frequencyandauditprotocoland

u(contract),themostsimpleandstraightforwardmethodis

throughthesuppliercompletedalf-designedincludethe

contentsoftheformtocarryoutexaminationandapproval

procedures.

4qualityauditprocedures

Describehowandbywhomthereviewandapprovalofbatch

records,intheprocessofinspection,andfinallytheAPItest

data,thequalityassurancedepartment(QA)mustbefinished

beforeenteringthemarkettheultimateresponsibility.

5nttotheproductiondepartmentforintermediatetest

processpersonnel

Allowtheproductionpersonnelmustcomplywiththedescription

oftheintermediatetestprocessrulesandstandards,suchas

checkbeforetheextractionsolutionpHetc..

6standard

Responsibleforthereviewandapprovalofnewrawmaterials,

intermediatesanddrugspecifications,personneldepartments

andprograms,suchasspecificationchanges,reviewand

approvalproceduresshouldalsobediscusdinthisarticle

inSOP.

7inspectionproceduresforapproval

Responsiblefortheinspectionofthepersonneldepartment,

inspectionprocedures,inspectionproceduresmaybethe

nationallegalstandards,inspectionproceduressuchasChina

PharmacopoeiaandAmericanPharmacopoeia,thenational

formularyisstandard,butifthisproceduredoesnotexistor

isnotsuitableforspecificmaterials,youcanuthetest

methodontheother.

8controlproceduresintheapprovalprocess

Describethecontrolprocessfordecisiveprogramverification

for.

9verificationmanualandreport

Describetheissuing,reviewandapprovalprocessvalidation

manualandreportrules.

10changecontrol

Whendescribingtheprocess,inspectionmethod,inspection

equipment,changeprocessorwillbechangedwhentheyhaveto

dothework,reviewandapprovalprocedures.

11samplingprocedures

Describethequalitycontroldepartmentstobeinformed,and

howtoidentifythesamplecollection,andputthemtothe

qualitycontrolroomfortransportation.

Theapprovalof12standardcontrolproducts

Accordingtothedescriptionoftherelatedprocess,lection

andapprovalofqualitycontrolpersonnelanddepartments.

13Analysisandevaluation

Accordingtothedescriptionoftherelatedprocess,lection

andapprovalofanalysisandevaluationofthepersonneland

departments.

14sampleapproval

Accordingtothedescriptionoftherelatedprocess,lection

andapprovaloftherelevantdepartmentsandpersonnel,

includingthelaboratoryreport.

15commissionedtheproductionmaterialaudit

Describeifintermediateisbythethirdpartytou

intermediatetestandproduction.

16stabilitytest

Thestabilitytestprocedures,includingtheconditions,

frequency,dataverificationanddocumentation.

17thecontractorevaluationandapproval

Howtodescribethelection,evaluationandapprovalofthe

contractor,forexampletheenterpricannotdelegate

externalinspectionetc..

The18batchrecordreview

Describehowandbywhomtheproductionrecordreviewand

signature.

19complaintsreview

Descriptionofcustomercomplaintsreceivedfromthe

evaluationaswellastothefinalresponishowtodealwith.

Theuofthematerialoutsidethe20specifications

Describewhenallowmaterialspecificationsandapproval

procedures,thecontentsinclude.

Theuof21returnedmaterials

Describestheuofreturnedmaterialmustbewhattodoand

whenacceptableorunacceptable.

22periodicreviewofSOP

DescribehowoftenexamineSOP(usuallyeverytwoyears),who

approvedtheaudit,andanyoneinvolvedinthereviewprocess.

Theestablishmentof23trainingrecords

Describewhogetthetrainingtheyget,whattypeoftraining,

trainingandtrainingfilesarekeptinwhereandbywhom.

24ofrawmaterials,intermediates,packagingmaterialsand

drugpurchasing,receiving,storageandtesting

Descriptionofallmaterialsishowtoarrangeandwhenthey

arereceiving,inspectionprocedures(achedlabel),

whereandhowtobestored(paratelocationsandqualified

materialssuchasquarantinearea)andrelocatedafterthe

qualified(qualifiedorunqualifiedarea).Restorageand

identificationproceduresarealsoapplicabletointermediates

anddrugs.

25unqualifiedmaterials

Descriptionoftheunqualifiedmaterialscanbereturnedtothe

supplier(suchaspurchainformSupplierandprepare

documents),itisstoreduntilitisshippedoutwhere.

26labelcontrol

Howisthedescriptiontagprinting,storage,controlandneed

tobetransportedtotheproductiondepartmentandother

relevantdepartments.(Note:savelabelareamustensure

trespasrsandlabelsmustbestrictlycontroltheamountof.)

Thereplacementof27workclothes

Describewhomustputonworkclothes(suchastheoperation

ofuniformedpersonnelandsupervisionpersonnelwearlabcoats)

toreplace,distribute,workuniformswhenandwhereandhow

oftenchangeclothes.

Controlofthe28airandwatersupplysystem

Foradescriptionoftheventilationandallwatersystemshow

often,bywhomisresponsibleforinspectionandcheckwhat

(includingdeionizedwaterwithendotoxinandmicrobial

analysisofitsprocess,specifications).

29laboratoryandproductionareapipelinesystem

identification

Describesasystemforidentifyingallofthelaboratoryand

productionareaofthepipeline,canbemixedcolorcode,arrow,

writtendescriptionandlabelu.

30cleaningprocedureforproductionequipment,utensilsand

containers

Thedescriptionmethodisvalidatedandapprovedtocleaneach

pieceofequipment.(aprocedureifveralreactiontank

cleaningproceduresarethesame,thenwritedownthe

descriptionofthiscleanreactiontankcancontainallthe

cleaning.)

31maintenanceofproductionequipment

Thenormaloperationdescribedhowoftenandwhatneedstobe

donetomaintaintheequipment.(needtosaveeachpieceof

equipmenttorecordandexplainwhattodointhemaintenance

timebywhommaintenance.)

Theprotectionandinspectionequipmentudin32

Descriptionofidleequipmentudinbetweenthetwoistobe

keptandmustbecarriedoutbeforebeingudagaintocheck,

shouldalsobethemostlongtimerecordidleexperience(not

morethan10daysortheneedforrecleaning).

33cleaningvalidationprocedures

Describeshowtodevelopthecleaningvalidationrules,bywhom

thereviewandapproval,andfilerecordsarekeptinwhere.

(includingresidues,cleaningagentsandbiologicalcontrolof

theloadfrequency.)

34equipmentcalibration

Describewhatcheckequipment,howoftentocheck,bywhomthe

calibrationtobemarked,andtherecordisstoredinwhere.

The35isnotudorcheckunqualifiedequipment

Describeshowtoidentifyequipment,whichisduetothefailure

ofthecheck,maintenance,maintenanceandneednotbeud.

36validationofcomputersystem

Specifywhencomputersystemisudintheproductionprocess

ncontentis

testedisthattheoperationofthesystem,topreventthe

occurrenceoffaultmeasures,errorchecking,recordthe

correction,restartanddatarecovery,changeoflicen,

changerecords,electronicsignature,manualinputdata

accuracycheck,databackup,urpermissions.

37logequipment

Udtodescribewhatequipment,whatproductproductionlog.

Note:ontents

havebeenincludedinthebatchproductionrecord.

The38mainproductionandcontrolrecordsprervation

Describeshowtosaveandcontrolthemainproductionrecords

(blankbatchrecords)andanalysisrecords(inspection

proceduresforqualitycontrol),mainproductionrecords

shouldberequiredbythequalityassurancedepartmentstore

intherightplace.

Savetheproductionandcontrolrecordsofthecomplete39

Describeshowtoprervetheintegrityoftheproduction

records(batchcompleterecords)andtestrecords(analysis),

therequirementsofthecompletebatchrecordsandinspection

reportbytheanalysisofthequalityassurancedepartment

storeandcontrol.

Reinspectioncycleof40ofallrawmaterialsandintermediates

Adetaileddescriptionofhowoften,whatmaterialsmustbere

mple:aftertheinspectionandacceptanceof

approval,havetwoyearsoftime,ifatthattimehasnotrun

outofallthematerialsremainingbeforeumustbere

iedafterextendedu,orforscrap

processing.

Amixtureofmorethan41batchesofproducts

Describeshowtomixedbatchesofproducts,ifyouwanttomix,

soeachbatchmustbetestedbystandardparametersafterall

avoidbatchesofAPImixture,

unlessabsolutelynecessary.

The42APItagidentification

shouldincludeacopy

ofthelabel.(thelabelsurfaceisdamagedcannotbeud.)

43batchtraceability

Thesystemcanbetracedandoperationproceduredescription

youwanttorecoverrelevantmaterials,thissystemrequires

morerigorous.

44oncefoundunqualified,resamplingofrawmaterials,

intermediatesandAPISandreinspection

Adetaileddescriptionofwhatthesituation,rawmaterials,

intermediateorAPIreinspectionatoncefoundunqualified,

includinghowtoreinspectedandallowedtou.

45validationofanalyticalprocedures

Describethecharacteristicsthatshouldbeconsideredforthe

analysisofverification,includingaccuracy,precision,

specificity,limitofdetectionandquantitationlimit,linear

rangeandextensivedegree,etc..

46tonotifycustomersabouttheproductionandprocesscontrol

procedurestodeterminethechange

Ifyouwanttochangeordescribeorixpectedtochangethe

productionandcontrolprocedureshavebeendeterminedwhenand

ldbenotedthatsmall

changesindifferentchanges,changesandcriticalchanges.

Test47reworkAPIandcertificateissued

WhentestingandqualificationarereprocesdAPIofany

mple,theAPIcaudby

unqualifiedstandardsforcriticalanalysisandevaluation

etc..

48mixedwithnewandrecycledsolvent

Describeshowtosaveanduthenewdistributionandrecovery

ofthesolvent,thesolventmixedwithnewandrecycledinthe

storagebinisveryinappropriate,onlywhentheyareaddedto

abatchofproductwhichcanbemixed,andmustbeinaccordance

withtheirrespectivespecificationscanbeudasqualified

productubeforeu.

Therecoveryof49APIS

Whenthedecisionisnecessarywhendescribingtherecoveryof

whatmustbedoneandwhonotice.

50ofthedrugsudforclinicaltrials

Thedescriptionudinclinicaltrialsfordrugproductionand

qualitycontrolmeasuresof"drugproductionquality

managementstandards"(GMP):thequality

standardandtherawmaterialsudintheproductionofthe

samemedicinalformal.