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CleaningvalidationWikipedia,thefreeencyclopedia

Cleaningvalidation
FromWikipedia,thefreeencyclopedia

Cleaningvalidationisthemethodologyusedtoassurethatacleaningprocessremovesresiduesoftheactive
pharmaceuticalingredientsoftheproductmanufacturedinapieceofequipment,thecleaningaidsutilizedin
thecleaningprocessandthemicrobialattributes.[1]Allresiduesareremovedtopredeterminedlevelstoensure
thequalityofthenextproductmanufacturedisnotcompromisedbywastefromthepreviousproductandthe
qualityoffutureproductsusingtheequipment,topreventcrosscontaminationandasaGMPrequirement.
TheU.S.FoodandDrugAdministration(FDA)hasstrictregulationaboutthecleaningvalidation.Forexample,
FDArequiresfirmstohavewrittengeneralproceduresonhowcleaningprocesseswillbevalidated.Also,FDA
expectsthegeneralvalidationprocedurestoaddresswhoisresponsibleforperformingandapprovingthe
validationstudy,theacceptancecriteria,andwhenrevalidationwillberequired.FDAalsorequirefirmsto
conductthevalidationstudiesinaccordancewiththeprotocolsandtodocumenttheresultsofstudies.The
valuationofcleaningvalidationisalsoregulatedstrictly,whichusuallymainlycoverstheaspectsofequipment
design,cleaningprocesswritten,analyticalmethodsandsampling.Eachoftheseprocesseshastheirrelated
strictrulesandrequirements.Regardingtotheestablishmentoflimits,FDAdoesnotintendtosetacceptance
specificationsormethodsfordeterminingwhetheracleaningprocessisvalidated.Butsomelimitsthathave
beenmentionedbyindustryincludeanalyticaldetectionlevelssuchas10PPM,biologicalactivitylevelssuch
as1/1000ofthenormaltherapeuticdoseandorganolepticlevels.[2][3][4]
CleaningValidationinthecontextofActivePharmaceuticalIngredientmanufacturemaybedefinedas:"The
processofprovidingdocumentedevidencethatthecleaningmethodsemployedwithinafacilityconsistently
controlspotentialcarryoverofproduct(includingintermediatesandimpurities),cleaningagentsandextraneous
materialintosubsequentproducttoalevelwhichisbelowpredeterminedlevels".

References
1.Agalloco,James(1992)." 'Pointstoconsider'inthevalidationofequipmentcleaningprocedures".PDAJournalof
PharmaceuticalScienceandTechnology46(5):1638.PMID1432455.
2.Jenkins,KMVanderwielen,AJArmstrong,JALeonard,LMMurphy,GPPiros,NA(1996)."Applicationoftotal
organiccarbonanalysistocleaningvalidation".PDAJournalofPharmaceuticalScienceandTechnology50(1):615.
PMID8846061.
3.Leblanc,DestinA(1998)."Establishingscientificallyjustifiedacceptancecriteriaforcleaningvalidationoffinished
drugproducts".PharmaceuticalTechnology22(10):13648.ISSN01478087.INIST:2430841.
4.FDAguidanceValidationofCleaningProcesses

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