picgmp简介翻译.docxVIP

PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME 国际医药品稽查协约组织(PIC/S) 2015年10月 GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS 良好生产规范药用产品的指南  INTRODUCTION 简介General综述In order to further facilitate the removal of barriers to trade in medicinal products, to promote uniformity in licensing decisions and to ensure the maintaining of high standards of quality assurance in the development, manufacture and control of medicinal products, the following Guide to Good Manufacturing Practice for Medicinal Products and its Annexes has been adopted. 为了进一步促进医药产品的贸易壁垒的去除，促进许可决定的一致性，确保质量保证在开发、制造和医药产品的控制方面高标准的维护，采用良好生产规范医药产品的以下指南及其附件。 The standards set out herein apply to medicines and similar products intended for human use. It is recommended, however, that the same kind of attention be given to the manufacture of veterinary products. Administrative measures of national health authorities should be directed towards the application of these standards in practice, and any new or amended national regulations for good manufacturing practice should at least meet their level. These standards are also intended to serve manufacturers as a basis for the elaboration of specific rules adapted to their individual needs. 本标准的制定适用于供人类使用的药品和类似产品。不过建议同样适用于兽药产品的生产。国家卫生当局的行政措施应针对这些标准在实践中的应用，新的或修订GMP国家规范至少应该满足他们的要求。这些标准也旨在为生产商作为特定规则的细化的基础适应他们的个人需求。这些标准也旨在为生产商提供细化的特定规则为基础以适应他们的个人需求 It is recognised that there are acceptable methods, other than those described in this Guide, which are capable of achieving the principles of the Guide. This Guide is not intended to place any restraint upon the development of new concepts or new technologies, which have been validated and provide a level of Quality Assurance at least equivalent to those set out in this Guide. 除了本指南中描述的，还有其他可以接受的方法能够实现指南中的原则。本指南并不想对新概念或新技术的发展进行任何限制，这些新概念或新技术已验证并提供至少相当于在本指南所述的质量保证水平。 The Guide is divided into two parts and a number of annexes which are common to both parts. Part I covers GMP pr