20140813EUGMP第3章厂房和

EUROPEANCOMMISSION

HEALTHANDCONSUMERSDIRECTORATE-GENERAL

PublicHealthandRiskAssessment

Medicinalproducts–quality,safetyandefficacy

Brussels,13August

Ares()

EudraLex

TheRulesGoverningMedicinalProductsintheEuropeanUnion

Volume4

EUGuidelinesfor

GoodManufacturingPracticefor

MedicinalProductsforHumanandVeterinaryUse

Part1

Chapter3:PremisesandEquipment

人药和兽药GMP指南第1部分第3章：厂房和设备

Legalbasisforpublishingthedetailedguidelines:Article47ofDirective/83/EContheCommunitycoderelatingtomedicinalproductsforhumanuseandArticle51ofDirective/82/EContheCommunitycoderelatingtoveterinarymedicinalproducts.Thisdocumentprovidesguidancefortheinterpretationoftheprinciplesandguidelinesofgoodmanufacturingpractice(GMP)formedicinalproductsaslaiddowninDirective/94/ECformedicinalproductsforhumanuseandDirective91//EECforveterinaryuse.

Statusofthedocument:Revision.

文件状态：修订

Reasonsforchanges:Theonlychangeistosection6aspartoftheimprovedguidanceonpreventionofcross-contaminationinvolvingalsoChapter5.

变更原因：仅对第6部分进行了变更以提高对防止交叉污染的指南，该内容在第5章也有涉及。

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