药品生产质量管理规范 _2010 _双语版参考用

英语对照2010GMP分享

药品生产质量管理规范（2010年修订）（卫生部令第79号）Good manufacturing Practice (Amended in 2010) (Ministry of Health order #79)

2011年02月12日发布

Issued on 12th Feb, 2011 《药品生产质量管理规范（2010年修订）》已于2010年10月19日经卫生部部务会议审

议通过，现予以发布，自2011年3月1日起施行。

Good manufacturing Practice (Amended in 2010) was published after approval by ministry of health and it will be implemented from 1st Jan, 2011.

部长:陈竺

Head: Chen Zhu

二○一一年一月十七日

17th Jan, 2011

第一章 总 则

Chapter 1 General Principles

第一条 为规范药品生产质量管理，根据《中华人民共和国药品管理法》、《中华人民共和国药品管理法实施条例》，制定本规范。

Article 1: In order to normalize the manufacture and quality control in drug production, this regulation is promulgated according to the Drug Administration Law of the People’s Republic of China and the Implementation Rules of Drug Administration Law of the People’s Republic of China.

第二条 企业应当建立药品质量管理体系。该体系应当涵盖影响药品质量的所有因素，包括确保药品质量符合预定用途的有组织、有计划的全部活动。

Article 2: There must be a Quality Assurance system incorporating all elements about product quality which include the total sum of the organized arrangements made with the object of ensuring that medicinal products are of the quality required for their intended use.

第三条 本规范作为质量管理体系的一部分，是药品生产管理和质量控制的基本要求，旨在最大限度地降低药品生产过程中污染、交叉污染以及混淆、差错等风险，确保持续稳定地生产出符合预定用途和注册要求的药品。

Article 3: As a part of Quality Assurance system, this regulation is the basic requirement of manufacture and quality control in drug production which aims at decrease the risk of contamination, cross-contamination, mix-up and errors in order to ensure that products are consistently produced and controlled to the quality standard appropriate to their intended use and as required by the Marketing Authorisation.

第四条 企业应当严格执行本规范，坚持诚实守信，禁止任何虚假、欺骗行为。

Article 4: Manufacturer is obliged to obey this regulation based on honest and faith. Any deceptive action is forbidden.

第1页下一页