GOOD LABORATORY PRACTICES

1 GOOD LABORATORY Drugs Controller, HQ,Drugs Control Dept. BangaloreINTRODUCTION NUMBEROFCOUNTRIESREQUIRETHEMANUFACTURERS TOPERFORMLABORATORYSTUDIESONSUCHPRODUCTS FORTHEIRPROPERTIESANDSAFETYANDTOSUBMITTH ERESULTSOFTHESESTUDIESTOGOVERNMENTAUTHOR ITY/REGULATORYAUTHORITIESFORTHEASSESSMEN TOFPOTENTIALHAZARDSTOHUMANHEALTHANDTHEEN VIRONMENTANDHAVEPASSEDLEGISLATIONTOTHATE FFECT. GoodLaboratoryPracticeshasbeenmadeaslawb yintroducingitasScheduleL-1whichisaNewSc heduleunderDrugsandCosmeticsRules,1945vi deGazettenotificationnoGSR780(E) ,Rule74,78andRule150 EoftheDrugsandCosmeticsRules, GoodLaboratoryPracticeshasbeenmadeaslawb yintroducingitasScheduleL-1whichisaNewSc heduleunderDrugsandCosmeticsRules,1945vi deGazettenotificationnoGSR780(E) ,Rule74,78andRule150 EoftheDrugsandCosmeticsRules, of GLP Good LABORATORY PRACTICES (GLP)is a qualitysystem concerned with the organizationalprocess and the conditions under which non-clinical health and environmental safetystudies areplanned, performed, monitored,recorded, archived and reported.

2 Good LABORATORY PRACTICES (GLP)is a qualitysystem concerned with the organizationalprocess and the conditions under which non-clinical health and environmental safetystudies areplanned, performed, monitored,recorded, archived and purpose of GLP The principle of Good LABORATORY practice(GLP) : to promote the development of qualityand validity of test data used for determiningthe safety ofchemicals, Pharmaceuticals,Food, Cosmetics etc. The principle of Good LABORATORY practice(GLP) : to promote the development of qualityand validity of test data used for determiningthe safety ofchemicals, Pharmaceuticals,Food, Cosmetics of G L PSincerawmaterials,packagingmaterials, ,Accuracy, ,packagingmaterials, ,Accuracy, vs. GLPS amplesLaboratoryProcessesResults ofAnalysisGood LABORATORY PracticesGood LABORATORY PracticesRaw MaterialsPackaging MaterialsManufacturingProcessesFinished Product ofStandard QualityGood Manufacturing PracticesSchedule-L1 (GLP) & House Keeping and , calibration, and validation of quality system Operating and Specifications and & House Keeping and , calibration, and validation of quality system Operating and Specifications and archivalFactors influencingimplementation &maintenance of GLP in laboratoryLaboratory Standards & reference microbial of analytical Reagents & of Volumetric glass of Standard solutions and reagent of Equipments / instruments & volumetric of Analytical methods specially documentation of analytical methods, specifications &protocol of of analysts.

3 Formal & informalGood Safety Standards & reference microbial of analytical Reagents & of Volumetric glass of Standard solutions and reagent of Equipments / instruments & volumetric of Analytical methods specially documentation of analytical methods, specifications &protocol of of analysts: formal & informalGood Safety Infrastructure General Chemical LaboratoryThespecificrequirementsare: Wellventilated,lightedandpreferablyairco nditionedtomaintainatemperatureof27 10C. Fittedwithproperlaboratoryfurnituresandf ixtures. Instrument Room:Thespecificrequirementsare: Temperature:25 10C Relativehumidity:45 5%. ConstantsupplyofElectricity Novibrationaldisturbances. Separateroomforhousingsemi-micro&microba lances. General Chemical LaboratoryThespecificrequirementsare: Wellventilated,lightedandpreferablyairco nditionedtomaintainatemperatureof27 10C. Fittedwithproperlaboratoryfurnituresandf ixtures. Instrument Room:Thespecificrequirementsare: Temperature:25 10C Relativehumidity:45 5%.

4 ConstantsupplyofElectricity Novibrationaldisturbances. Separateroomforhousingsemi-micro& Infrastructure Microbial LABORATORY : Airconditioned,preferablywithAHUwithsuit ablefilter(5micronorless). Fittedwithproperlaboratoryfurnitures&fix turesandachangeroom. Forunitshavingbothsterile&non sterileproductsthereshouldbetwoasepticzo neshavingclass1000areawithLAFandentrythr oughgradedairzones, ,oneasepticzoneshallbethere. Microbial LABORATORY : Airconditioned,preferablywithAHUwithsuit ablefilter(5micronorless). Fittedwithproperlaboratoryfurnitures&fix turesandachangeroom. Forunitshavingbothsterile&non sterileproductsthereshouldbetwoasepticzo neshavingclass1000areawithLAFandentrythr oughgradedairzones, , Infrastructure Hot Zone:For housing Hot Air Oven, Muffle Furnace, FumeCupboard, Autoclaves etc. one Hot Zone is required. Thiszone should have proper ventilation system. Package Material Testing Section:Thespecificrequirementsare: Adequate space, Required equipments and instrument.

5 Furnitures & Fixtures. Hot Zone:For housing Hot Air Oven, Muffle Furnace, FumeCupboard, Autoclaves etc. one Hot Zone is required. Thiszone should have proper ventilation system. Package Material Testing Section:Thespecificrequirementsare: Adequate space, Required equipments and instrument. Furnitures & Infrastructure Retained Sample Area:Thisisrequiredforstorage&preservati onofretainedsamplesofbothfinishedproduct sandactiverawmaterialsThespecificrequire mentsare: Propertemperaturecontrol(whereverrequire d) Properdemarcationforfinishedproductsanda ctiverawmaterials. CleaningArea:Thespecificrequirementsare: Suitablesize Providedwithfacilitieslikerunninghotandc oldwater,purifiedwater,differentcleaning agentsforglassapparatus. Retained Sample Area:Thisisrequiredforstorage&preservati onofretainedsamplesofbothfinishedproduct sandactiverawmaterialsThespecificrequire mentsare: Propertemperaturecontrol(whereverrequire d) Properdemarcationforfinishedproductsanda ctiverawmaterials.

6 CleaningArea:Thespecificrequirementsare: Suitablesize Providedwithfacilitieslikerunninghotandc oldwater,purifiedwater, Infrastructure Storage Area for Lab Chemicals, Glass Apparatus &Miscellaneous Items:There should be an adequate area with proper demarcation andproper temperature control wherever required for storage oflaboratory chemicals, solvent, glass apparatus & addition to these, there should be adequate arrangementsfor all types of services like vacuum, compressed air, nitrogen,potable water, purified water, ultra-pure water etc. indifferent sections of Lab. Storage Area for Lab Chemicals, Glass Apparatus &Miscellaneous Items:There should be an adequate area with proper demarcation andproper temperature control wherever required for storage oflaboratory chemicals, solvent, glass apparatus & addition to these, there should be adequate arrangementsfor all types of services like vacuum, compressed air, nitrogen,potable water, purified water, ultra-pure water etc.

7 Indifferent sections of Standard PrimaryreferenceStandardsforactive&inact ivebulkdrugsofIP,BPCRS,EPCRS,USPgrade Referencestandardsforimpuritieswherevera pplicableandavailable Procurementfromrespectiveauthoritieslike CentralDrugsLaboratory,Kolkata;UnitedSta tesIPCommission,PharmacopoeiaConvention( USPC)etc. ProperPreservation( ) PrimaryreferenceStandardsforactive&inact ivebulkdrugsofIP,BPCRS,EPCRS,USPgrade Referencestandardsforimpuritieswherevera pplicableandavailable Procurementfromrespectiveauthoritieslike CentralDrugsLaboratory,Kolkata;UnitedSta tesIPCommission,PharmacopoeiaConvention( USPC)etc. ProperPreservation( )Reference Standard DevelopmentofsuitableworkingStandardfrom availableactiverawmaterialswiththehelpof theseprimarystandards. IdentificationandStorageofworkingstandar dswithexpirydate,retestdateandotherappro priateinformation. Documentationofallinformationregardingth eseprimarystandardsandworkingstandards. DevelopmentofsuitableworkingStandardfrom availableactiverawmaterialswiththehelpof theseprimarystandards.

8 IdentificationandStorageofworkingstandar dswithexpirydate,retestdateandotherappro priateinformation. Microbial Cultures Referencemicrobialcultures ProcurementfromCentralDrugsLaboratory,Ko lkata;NationalCollectionofTypeCulture( ) ( ) ProperMaintenanceinthemicrobiallabasperr espectivepharmacopoeia. Properdocumentation. Referencemicrobialcultures ProcurementfromCentralDrugsLaboratory,Ko lkata;NationalCollectionofTypeCulture( ) ( ) ProperMaintenanceinthemicrobiallabasperr espectivepharmacopoeia. Reagents & GlasswareTwogradesofvolumetricglasswarea reusedinthelaboratoryClassA:withtestcert ificate, :withtestcertificate, of Standard solutionsand reagentAllstandardsolutions(referencesta ndardsandvolumetricStandards)andreagents solutionmusthaveproperlabelsindicatingna me,strength,dateofpreparation, (referencestandardsandvolumetricStandard s)andreagentssolutionmusthaveproperlabel sindicatingname,strength,dateofpreparati on, of Analytical ProcedureAllnonPharmacopoeialanalyticalm ethodshavingtestsforidentity,impurity/im purities&purityaretobevalidatedproperlyb eforeuseinrespectof (as applicable for each individual method).

9 ,impurity/impurities&purityaretobevalida tedproperlybeforeuseinrespectof (as applicable for each individual method). of Equipments andinstrumentsCalibrationisthecomparison oftheperformanceofameasuringequipment/ , , of :Somemeasuringequipments/instrumentslike pressuregauge,thermodials,glassthermomet ers,wetanddrybulbhygrometers, :SomemeasuringinstrumentslikeUVVISS pectrophotometer, :Somemeasuringequipments/instrumentslike pressuregauge,thermodials,glassthermomet ers,wetanddrybulbhygrometers, :SomemeasuringinstrumentslikeUVVISS pectrophotometer, of ,gaschromatograph, : : ,gaschromatograph, : : LABORATORY personnel (managers, supervisory staffs,analysts, technicians, helpers and others) should haveregular training can be of two types training :This may cover different topicslike analytical chemistry, statistical techniques,microbial techniques, instrumental techniques,electronic data processing, documentation training :Informal or on the job traininginvolves LABORATORY skills.

10 Records of training must be LABORATORY personnel (managers, supervisory staffs,analysts, technicians, helpers and others) should haveregular training can be of two types training :This may cover different topicslike analytical chemistry, statistical techniques,microbial techniques, instrumental techniques,electronic data processing, documentation training :Informal or on the job traininginvolves LABORATORY skills .Records of training must be & RecordsUsualDocumentandrecordswithwhichQ CLaboratoryhastodealwithare Specification TestProcedure StandardOperatingProcedures CertificateofAnalysiswithrelevantTestPro tocols SampleRegister RegisterforReferenceStandards&ReferenceC ultures CalibrationRecords ValidationRecords TrainingRecords RecordsforRetainedsamples(Bothfinishedpr oducts&activerawmaterials) Recordspertainingtothepreparationofsolut ionsofreferencestandards,volumetricsolut ionsandotherreagents. Logbookforinstruments& Specification TestProcedure StandardOperatingProcedures CertificateofAnalysiswithrelevantTestPro tocols SampleRegister RegisterforReferenceStandards&ReferenceC ultures CalibrationRecords ValidationRecords TrainingRecords RecordsforRetainedsamples(Bothfinishedpr oducts&activerawmaterials) Recordspertainingtothepreparationofsolut ionsofreferencestandards,volumetricsolut ionsandotherreagents.