Transcription of GOODPRACTICE GUIDELINES - EDQM
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GOODPRACTICE GUIDELINES - EDQM
1 GOODPRACTICEGUIDELINESFor ImplementingStandardsandSpecificationsfo rthe QualitySysteminBloodEstablishmentsIntrod uctory NoteGoodPracticeGuidelineshavebeenprepar edthrough anad hocco-operationbetweenthe EuropeanDirectoratefor the QualityofMedicines& HealthCare ofthe Councilof Europe(EDQM/CoE)and theCommissionofthe EuropeanUnion (EU).These GoodPracticeGuidelinesare includedinthis 19thEditionof the Guide tothe preparation, use andquality assurance ofbloodcomponents, Appendix toRecommendation No. R (95)15ofthe Committee ofMinisters onthe preparation,use and quality assurance ofblood ,accordingtoDirective2005/62/EC,that thequalitysysteminplaceinallbloodestabli shments complieswiththestandards andspecificationsset toimplementthestandardsandspecifications setoutinthe AnnextoDirective2005/62/EC,itsArticle 2,asamendedbyDirective(EU)2016/1214,isre placedbythefollowing: MemberStatesshall ensurethat, inordertoimplementthestandardsandspecifi cationssetoutintheAnnextothis Directive, therearegoodpracticeguidelinesavailablet oandusedbyallbloodestablishments, intheirqualitysystem,goodpracticeguideli neswhich takefullyintoaccount, where relevantfor bloodestablishments, thedetailedprinciples andguidelines ofgoodmanufacturingpractice, asreferred tointhefirst subparagraphofArticle 47ofDirective 2001/83/EC.
2 Goodpractice guidelines for blood establishments and hospital blood banks 1.Generalprinciples 1.1. Generalrequirements 1.1.1. Eachbloodestablishmentmu
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