EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERALPublic Health and Risk AssessmentMedicinal Product quality, safety and efficacyBrussels, 16 August 2013EudraLexThe Rules Governing Medicinal Products in the European UnionVolume 4EU Guidelines forGood Manufacturing Practice forMedicinal Products for Human and Veterinary UsePart 1Chapter 2: Personnel人药与兽药GMP指南 第2章:人员Legal basis for publishing the detailed guidelines: Article 47 of Directive 2001/83/EC on the