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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 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.

Good Manufacturing Practices. Schedule-L1 (GLP) 1. General requirements 2. Premises 3. Personal 4. Equipments 5. Chemicals & Reagents ... potable water, purified water, ultra-pure water etc. in different sections of Q.C. Lab. ... the pharmaceutical industry there is no ...

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