gmpchapter6en2013欧盟指南质量控制.docVIP

EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Public Health and Risk Assessment Medicinal products – quality, safety and efficacy Brussels, date EudraLex The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Part 1 Chapter 6: Quality Control Legal basis for publishing the detailed guidelines: Article 47 of Directive 2001/83/EC on the Community code relating to medicinal products for human use and Article 51 of Directive 2001/82/EC on the Community code