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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 concer

6. Good House Keeping and Safety 7. Maintenance , calibration, and validation of equipments 8. Reference materials 9. Microbiological cultures 10. Quality system 11. Internal quality system audits 12. Management review 13. Standard Operating Procedures 14. Protocols and Specifications archive 15. Raw data 16. Storage and archival

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