欧盟GMP指南第5章生产（中英文20150123）.pdfVIP

欧盟GMP指南第5章生产（中英文）

EUGMP第1部分第5章生产

——增加基因毒性的评估生效时限

2015-02-2511:50:00

（粉色字为2015年1月23日新增内容，红字斜体为2014年8

月13日修订内容）

Ref.Ares(2015)283689-23/01/2015EUROPEAN

COMMISSION

HEALTHANDCONSUMERSDIRECTORATE-GENERAL

PublicHealthandRiskAssessment

Medicinalproducts–quality,safetyandefficacy

Brussels,13August2014

Ares(2014)2674301

EudraLex

TheRulesGoverningMedicinalProductsintheEuropean

Union

Volume4

EUGuidelinesfor

GoodManufacturingPracticefor

MedicinalProductsforHumanandVeterinaryUse

Part1

Chapter5:Production

人兽药EUGMP指南

第1部分

第5章：生产

Legalbasisforpublishingthedetailedguidelines:Article47

ofDirective2001/83/EContheCommunitycoderelatingto

medicinalproductsforhumanuseandArticle51ofDirective

2001/82/EContheCommunitycoderelatingtoveterinary

medicinalproducts.Thisdocumentprovidesguidanceforthe

interpretationoftheprinciplesandguidelinesofgood

manufacturingpractice(GMP)formedicinalproductsaslaid

downinDirective2003/94/ECformedicinalproductsforhuman

useandDirective91/412/EECforveterinaryuse.

Statusofthedocument:Revision[a]

Reasonsforchanges:Changeshavebeenmadetosections

17to20toimprovetheguidanceonpreventionofcross-

contaminationandtorefertotoxicologicalassessmentguidance.

Changeswerealsointroducedinsections26to28onthe

qualificationofsuppliersinordertoreflectthelegalobligation

ofmanufacturingauthorisationholderstoensurethatactive

substancesareproducedinaccordancewithGMP.Thechanges

includesupplychaintraceability.Section(33)isinsertedtoclarify

andharmoniseexpectationsof