精选优质文档-倾情为你奉上EUROPEAN COMMISSIONENTERPRISEDIRECTORATE-GENERALSingle market, regulatory environment, industries under vertical legislationPharmaceuticals and cosmeticsBrussels,30 March 2015EudraLex欧盟药品管理法Volume 4EU Guidelines forGood Manufacturing Practice forMedicinal Products for Human and Veterinary Use第四卷 欧盟人用和兽用药品GMP指南Annex 15: Qualification and Validation附录15:确认和验证Legal basis for publishing the detailed guidelines:Article 47 of Directive 2