16 Basic Principles of GMP
1.Drugsproductionenterprisesmusth***eenoughtechnicianswhoarequalifiedandmeetthestandardofdrugsproduction.Moreover,theymustresp***ibleforthedrugproductionandqualityproductionandknowclearlywhattheyshoulddo.2.Operatorsshouldbetrainedsothattheycanoperatecorrectly.3.Enterprisesmustensuretheproductionareproducedandcontrolledunderthequalitystandard.4.Enterprisesmustmakeproductionorderaccordingtoproductiontask,butnottoproductionplan.5.Allproductionmustproducedunderthetechnologicalprocedure,checkedsystematicallyandcanbeprovedtomeetthequalityandspecificationstandard.6.Ensurethatproductionfactory,environment,productionfacilityandhygieneshouldmeettherequirements.7.Materials,packingcontainersandtagswhichmeetspecificationstanda***.8.Suitablestorageandtransportingequipment.9.Thewholeproductionprocessmustbecontrolledandmanagedrigorouslyandefficiently.10.Thekeystepsandmainchangesofprocessingproductionmustbechecked.11.qualifiedqualityinspectors,facilitiesandlabs.12.Itmustberecordedbymanorrecorderduringtheproductionsothatalltheproductionstepswhicharefinishedmeetthespecificationandinstructi***andproductsmeetprospectivequantityandquality.Besides,anydeviationmustberecordedandinvestigated.13.Thedangerwhichaffectthestorageandsellingoftheproductsmustdecreasetotheminimum.14.Setupaneffectivesystemthatcanwithdrawanyproductsthroughsellingandsupplying.15.Toknowabouttheclients’ideasandtoinvestigatethecauseofqualityproblemssothatwecanputforwardsomemeasurestohandleitandpreventitnottohappenagain.16.Anewproductionprocess,productivetechnology,facilityandmaterialmustbecheckedtoachievetheanticipatedresults.O***unda,theonlyc***ultingorganizationwhichfocusesinthefieldofmedicaldevice,inwhichtherearetensoftopc***ultantswhocanprovideGMPcertification,GMPcertificationc***ulting,GMPsystemcertificationc***ultingforenterprises,hassetupsevenwhollyownedsubsidiariesinGuangzhou,Beijing,Shanghai,Shenzhen,Jinan,SuzhouandAmerica,hasprovidedfullysoluti***tomorethan1500medicaldevicefactoriessuccessfully.)