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)

3 & 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: 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.

4 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%. ConstantsupplyofElectricity Novibrationaldisturbances. Separateroomforhousingsemi-micro& Infrastructure Microbial LABORATORY : Airconditioned,preferablywithAHUwithsuit ablefilter(5micronorless). Fittedwithproperlaboratoryfurnitures&fix turesandachangeroom.

5 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. Furnitures & Fixtures.

6 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.

7 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.

8 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.

9 IdentificationandStorageofworkingstandar dswithexpirydate,retestdateandotherappro priateinformation. Documentationofallinformationregardingth eseprimarystandardsandworkingstandards. DevelopmentofsuitableworkingStandardfrom availableactiverawmaterialswiththehelpof theseprimarystandards. IdentificationandStorageofworkingstandar dswithexpirydate,retestdateandotherappro priateinformation. Microbial Cultures Referencemicrobialcultures ProcurementfromCentralDrugsLaboratory,Ko lkata;NationalCollectionofTypeCulture( ) ( ) ProperMaintenanceinthemicrobiallabasperr espectivepharmacopoeia. Properdocumentation. Referencemicrobialcultures ProcurementfromCentralDrugsLaboratory,Ko lkata;NationalCollectionofTypeCulture( ) ( ) ProperMaintenanceinthemicrobiallabasperr espectivepharmacopoeia.

10 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). ,impurity/impurities&purityaretobevalida tedproperlybeforeuseinrespectof (as applicable for each individual method).