生产过程质量控制点监测管理制度.docx
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生产过程质量控制点监测管理制度.docx
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生产过程质量控制点监测管理制度
生产过程质量控制点监测管理制度(Monitoringandmanagementsystemofqualitycontrolpointsinproductionprocess)
Monitoringandmanagementsystemofqualitycontrolpointsinproductionprocess
2007-6-160:
00:
00China114networkbrowsing:
2001veterinarydrugtrade
CompanyGMPmanagementdocuments
Subject
Monitoringandmanagementsystemofqualitycontrolpointsinproductionprocess
Code:
SMP-SC-0160-00
Atotalof7pages
Formulate
Toexamine
Approval
Dateset
Auditdate
Approvaldate
Issuingdepartment
Office
Quantityissued
effectivedate
Distributionunit
Office,productiontechnologydepartment,qualitydepartment,materialsupplydepartment,EngineeringDepartment
I.Objective:
toformulatethemonitoringandmanagementsystemforimportantqualitycontrolpointsintheproductionprocess,soastoensurethestrictcontrolofthequalityoftheproductsineachproductionlink.
Two.Scopeofapplication:
itisapplicabletoqualitycontrolintheproductionprocessofproductiontechnologydepartment.
Three、responsibility:
productiontechnologymanager,QAinspector.
Four,text:
Inordertoensurethequalityoftheproducts,thequalityoftheproductionprocessmustbemonitoredandcontrolled,andthequalitycontrolpointsoftheproductionprocessandthesupervisionandmanagementsystemareasfollows:
1finalsterilesmallvolumeinjection
2.1purifiedwater,waterforinjection:
claritymustmeetthestandards
2.2ampoulewashinganddryingsterilization:
inthereadyroomoffthepackagingintotheroughroughwashwashroom,washroomevacuationintowashingwallshouldberinsedwithpurifiedwater,theinnerwallofatleasttwotimes,finallyrinsewithwaterafterinjectionof0.45mmembranefiltrationqualifiedclarity,drying,sterilizing,cooling,ampouleaftersterilizationshouldbeusedimmediatelyorstoredcleanstorageshallnotexceed2days,afterwashingbottlesshouldbecleanandclaritycheck.
1.3weighing:
beforeweighing,shouldchecktherawmaterials,name,batchnumber,manufacturer,specifications,shouldbeconsistentwiththeinspectionreport.Whenchangingtherawandauxiliarymaterialssupplier,thereshouldbeasampletestcertificateoraverifiedreport;whenweighing,theremustbeareviewer;theoperatorandthereviewershouldsignontheoriginalrecord.
1.4,preparation:
thepreparationtankmustmarkthename,specification,batchnumberandpreparationquantityofthepreparationliquid,andthematerialmustbereviewedandrecordedwhenfeeding.
1.5coarsefiltrationandfinefiltration:
afterthecontentofliquidmedicine,pHvalueofqualifiedinspection,canbecarefullyfiltered,thecontainersshouldbeclosed,indicatingthevarietyofliquidmedicine,specifications,batchnumber.Thepreparationofliquidmedicinetosterilizationshouldbecompletedwithin24hours.
1.6,potting:
fillingpipes,needles,beforeuse,withinjectionwaterwashedandboilingsterilization,directlyconnectedwiththesolution
Theinertgasandcompressedairarepurifiedbeforeuse,andtheirpurityandparticlesizeshouldbeinaccordancewiththeregulations,andthefillingcapacityshallbefilledaccordingtotherelevantprovisions.Asmallsampleofsemi-finishedtimelycheckclarity,loading,sealingquality,semi-finishedcontainershouldindicatetheproductname,specifications,batchnumber,date,fillingandsealingmachinenumberandsequencenumber,nameoftheoperator.
1.7:
doubleleaftypesterilizationsterilizationcabinetproductsbeforesterilization,tocheckthename,batchnumber,quantity,accordingtothestandardoperationprocedureofsterilization,sterilizationshouldbetimelyrecord,andpaycloseattentiontotemperature,pressureandtime,ifthereisabnormalsituationshouldbepromptlydealtwith.Leakdetectionaftersterilization,vacuumdegreeofleakdetectionat-8kpa.
1.8lampinspection:
inspector'seyesightisabove0.9,
Visualinspectiononceayear,aftertheinspectionofsemi-finishedproductsshouldindicatethenameoftheexaminer,byhandspotcheck.Theunqualifiedproductstimelyclassificationrecords,indicatingthename,specifications,code,batchnumber,placedinthecontainertransferspecialtreatment.
1.9printingpacking:
thename,specification,batchnumberandquantityofsemi-finishedproductsshouldbecheckedwhethertheyareinaccordancewiththepackingmaterials.Intheprocessofprinting,packaging,packingshouldalwayscheckthename,batchnumber,specifications,packagingafterthedamageandtheremainingnumberandcollarnumber,goodpracticalstatisticsforpackagingmaterialsforthenumberofmaterialbalancecheck,endevacuationquarantinequarantine,inspectionafterstorage.
2oralliquid
2.1configurationandfiltration
2.1.1configurationinvolvesequipment,containers,piping,filterplates,cleanedwithhotwaterbeforeuse.
2.1.2oralliquidshouldbecompletedwithin4~5hours,mainlyreferstothecontinuousoperationaccordingtotheproductionplan.
2.1.3thepreparedliquidshouldbefilteredtothedilutemixingtankintime.
2.2potting
2.2.1fillingprocessinvolvesthefillingequipment,containers,bottles,storagetanks,pipes,beforeuse,cleanwithhotwater.
2.2.2continuousoperationaccordingtofillingpositionoperationrules,thefillingoforalagentshouldbecompletedwithin8hours.
2.2.3sterilization
Beforetheoperatorenterstheworkroom,theultravioletlampshouldbeopenedtoirradiateandsterilize.
Oralpreparationofliquidmedicineinpreparationprocessboil,heatpreservation30minutessterilization.
3Powder
3.1weighingandbatching:
3.1.1rawmaterialsorintermediateproductsbeforeweighingshallbecleanedorremoved,andthematerialname,specificationandbatchnumbershallbecarefullycheckedandshouldbeinconformitywiththeinspectionreportandcertificate.
3.1.2prescriptioncalculation,weighinganddeliverymustbereviewedandtheoperatorandreviewershouldsignontherecord.
3.1.3therawmaterialofthebatchispackedinthecontainerandmarkedwiththename,batchnumber,specifications,quantity,weighingpersonanddate.
3.2mix:
3.2.1beforemixing,checkthematerialname,batchnumber,quantity,etc.,confirmtheerror,andthenproceedtothenextstep.
Theamountof3.2.2generallydoesnotexceed2/3ofthetotalcapacityoftheaircraft.
3.2.3mixesthehomogeneousmaterialintoabatchandmakesupabatchnumber.
3.3packagingprocess:
3.3.1preparationbeforepacking:
3.3.1.1priortotheinspectionofthepackingarea:
checkwhetherthereareanyitemsintheproductionareawhichhavenothingtodowiththebatchproduction.
3.3.1.2shouldnotdealwithdifferentbatchesofproductsinthesamepackagingroomatthesametime.
Acceptanceof3.3.1.3productsandpackagingmaterials:
checking,checkingandverifyingthecodes,batchnumbers,commoditynamesandquantitiesofpackingmaterialsandproductsinaccordancewiththebatchproductionrecord.
3.3.1.4batchnumberandvaliditycheckprinting:
inmanualormachineprintingbatchnumber,productiondate,thevalidityoftheprocess,accordingtothebatchrecordshouldcarefullycheckthecarton,packingbags,labels,inspectioncertificatesprintedoncompliancewithrequirements.
3.3.2packagingoperations:
3.3.2.1atthestartoftheexamination:
firstsetthebatchnumber,productiondate,theperiodofvalidityofthelabelandcertificateshallbeattachedtothebatchfile,andmanualprintingandpackagingmaterialsshouldalsobeincludedinthebatchfileandsampling.
3.3.2.2checkthebatchproductionrecordandcheckthefirstpackingunit,
Haveyouusedanypackingmaterialthatshouldbeusedandifthereisanydefectinthepackage?
.
3.3.2.3checkthebatchnumber,dateofmanufactureandvalidityoftheprintingiscorrect,thehandwritingisclear.
3.3.3packingprocess:
thepackingprocessshouldbecheckedwiththeouterpackingboxandtheinstructionmanual,andthepackingoperationcanbecarriedoutwithouterror.
3.3.4filearchiving:
-fillintheintermediatecontrolrecordscorrectly,withoutomission;
-samplesofprintedpackingmaterialsarecompleteandcorrect.Thefinaldocumentsmustbesenttothequalitydepartment.
3.3.5clearance:
Theproductionsiteinbatchesandreplacingvarieties,specifications,accordingtotherequirementsofclearanceclearancemanagement.WeshouldhangsignsQAclearanceafterpassingtheacceptance.
4disinfectant
4.1weighing:
beforeweighing,shouldchecktherawmaterials,name,batchnumber,manufacturer,specifications,shouldbeconsistentwiththeinspectionreport.Whenchangingtherawandauxiliarymaterialssupplier,thereshouldbeasampletestcertificateoraverifiedreport;whenweighing,theremustbeareviewer;theoperatorandthereviewershouldsignontheoriginalrecord.
4.2,preparation:
thepreparationtankmustmarkthename,specification,batchnumberandpreparationquantityofthepreparationliquid,andthematerialmustbereviewedandrecordedwhenfeeding.
4.3filling:
fillingcapacityaccordingtotherelevantprovisionsoffilling.Asmallsampleofsemi-finishedtimelycheckclarity,loading,sealingquality,semi-finishedcontainershouldindicatetheproductname,specifications,batchnumber,date,fillingandsealingmachinenumberandsequencenumber,nameoftheoperator.
4.4printingpacking:
thename,specification,batchnumberandquantityofsemi-finishedproductsshouldbecheckedwhethertheyareinaccordancewiththepackingmaterials.Intheprocessofprinting,packaging,packingshouldalwayscheckthename,batchnumber,specifications,packagingafterthedamageandtheremainingnumberandcollarnumber,goodpracti
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- 关 键 词:
- 生产过程 质量 控制 监测 管理制度