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GOOD LABORATORY PRACTICES

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 P

laboratory Class A: with test certificate, as per specification laid down by B.I.S. Class Bas B.I.S. Class A are to be used for Work of the highest accuracy like standardization of volumetric solutions & Class B for routine work. Cleanliness of glassware should be ensured before use and periodic validation in this respect are to be done.

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