EU GMP第六章质量控制- quality control 翻译.docVIP

Chapter 6: Quality Control 第1部分第6章：质量控制 ? 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 relating to veterinary medicinal products. This document provides guidance for the interpretation of the principles and guidelines of good manufacturing practice (GMP) for medicinal products as laid down in Directive 2003/94/EC for medicinal products for human use and Directive 91/412/EEC for veterinary use. 出版详细指南的法律依据：指令2001/83/EC第47条关于人药统