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GOOD LABORATORY PRACTICES

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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) ,Rule74,78andRule150EoftheDrugsandCosmet icsRules, GoodLaboratoryPracticeshasbeenmadeaslawb yintroducingitasScheduleL-1whichisaNewSc heduleunderDrugsandCosmeticsRules,1945vi deGazettenotificationnoGSR780(E) ,Rule74,78andRule150EoftheDrugsandCosmet icsRules, 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.

process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, ... ðvFor units having both sterile & non sterile products ... involves laboratory skills . Records of training must be kept.

  Skills, Process, Sterile

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