EUGMPpart1chapter520150301实施-中英文.docxVIP

EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERALPublic Health and Risk AssessmentMedicinal products – quality, safety and efficacyBrussels, 13 August 2014Ares(2014)2674301EudraLexThe Rules Governing Medicinal Products in the European UnionVolume 4EU Guidelines forGood Manufacturing Practice forMedicinal Products for Human and Veterinary UsePart 1Chapter 5: Production人兽药EU GMP指南第1部分第5章：生产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.Status of the document:Revision.Reasons for changes: Changes have been made to sections 17 to 20 to improve the guidance on prevention of cross-contamination and to refer to toxicological assessment guidance. Changes were also introduced in sections 26 to 28 on the qualification of suppliers in order to reflect the legal obligation of manufacturing authorisation holders to ensure that active substances are produced in accordance with GMP. The changes include supply chain traceability. Section (33) is inserted to clarify and harmonise expectations of manufacturers regarding the testing of starting materials while section (68) introduces guidance on notification of restrictions in supply.变更理由：对17-20条进行变更，以改进指南中防止交叉污染的部分，及引用毒理学评估指南。还增加了26-28条关于供应商确认部分，以反映上市许可持有人所承担的保证活性物质根据GMP要求生产的责任。变更包括供应链可追溯性。加入第33条，以澄清并保持关于原辅料生产商期望一致性，增加68条中引入了供应受限通知的内容。Deadline for coming into operation:1 March 2015生效日期：2015年3月1日PrincipleProduction operations must follow clearly defined procedures; they must comply with the principles of Good Manufacturing Practice in order to obtain produc