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1、PahwaetalTropicalJournalofPharmaceuticalResearch,February2010;9(1):81-90©PharmacotherapyGroup,FacultyofPharmacy,UniversityofBenin,BeninCity,300001Nigeria.Allrightsreserved.Availableonlineathttp://www.tjpr.orgReviewArticleValidationAspectsofWaterTreatmentSystemsforPharmaceu
2、ticalProducts1*11RakeshPahwa,MonaPiplani,PrabodhCSharmaandArun2Nanda12InstituteofPharmaceuticalSciences,KurukshetraUniversity,Kurukshetra-136119,DepartmentofPharmaceuticalSciences,MaharshiDayanandUniversity,Rohtak-124001,IndiaAbstractThegoalofconductingvalidationistodemons
3、tratethataprocess,whenoperatedwithinestablishedlimits,producesaproductofconsistentandspecifiedqualitywithahighdegreeofassurance.Validationofwatertreatmentsystemsisnecessarytoobtainwaterwithalldesiredqualityattributes.Thisalsoprovidesaframeworktoestablishatotalcontroloverth
4、eprocesswhichmonitorssafety,efficacyandultimately,theprocessoutcomes.Thepresentoverviewisanattempttodiscussvariousaspectsofvalidationincludingdifferentapproaches,componentsofwatertreatmentsystems,equipmentqualifications,phasesofperformancetesting,documentationandpost-valid
5、ationmonitoring.Keywords:Validation;Watertreatmentsystems;Qualityattributes;Pharmaceuticalproducts.Received:29June2009Revisedaccepted:30October2009*Correspondingauthor:E-mail:rakesh_pahwa2407@yahoo.co.in;Tel:+91-9896250793TropJPharmRes,February2010;9(1):81PahwaetalINTRODUC
6、TIONassuranceprogramme.ValidationislegiblethroughthedocumentationestablishmentWatermaybereferredtoas‘theelixiroflife’-anditguaranteesamanufacturingprocessThistermismostapttothepharmaceuticalwithassuredproductqualityandindustryforwhichthequalityofwaterishomogeneity.Validati
7、onofwatertreatmentcriticalandahighpriority.Itisanessentialsystemsismandatorytoobtainwaterwithallingredientofvariouspharmaceuticalthedesiredqualitycharacteristics[4].preparationsandisalsousedtocleanPharmaceuticalwaterproduction,storageprocessequipmentandhence,playsaandconve
8、yancesystemshouldbevalidatedpivotalroleinpharmaceuticalprocessings[1].becauseend-productt