中国新版GMP与欧盟、美国GMP比较概要

New Chinese, EU and US GMPs comparative overview

中国新版，欧盟和美国GMP

比较概要

Date: 24 – February – 2011

日期：2011年2月24日

Authors作者：: Víctor Samitier (TDV) / Octavi Colomina (TDV)

1.Quality Management 质量管理

SIMILARITIES 相似点:

EU and new Chinese GMPs set forth the requirement of establish a quality system, with their own quality objectives, applying all of requirements on safety, efficacy and quality control related with drug registration to the whole process of drug production. EU and new Chinese GMPs introduce the concepts of Quality Assurance in the same way. US GMPs does not establish the requirement of having a quality system, but it can be understood with the whole reading of 21 CFR Parts 210 &211.

欧盟和新版中国GMP都建立了质量系统要求，包括了确立相应质量目标，应用从药品注册到整个药品生产工艺的安全，成效和质量控制。欧盟和新版中国GMP引入了相同的质量保证概念。美国GMP并没有建立质量系统的需求，但是通过对21CFR Parts 210和211的解读能够体现质量系统概念。

Again EU and new Chinese GMPs introduce clearly the Risk Management Approach according to ICH Q9 concepts. Conversely, 21 CFR does not mention these concepts which are much newer than last revision of US GMPs.

欧盟和中国新版GMP又再次重申了了由ICH Q9引出的质量管理方法。相对陈旧的美国GMP 21CFR 没有涉及到这些最新概念。

DIFFERENCES 差异点:

New Chinese GMPs identifies the responsibility of top management personnel for the implementation of quality objectives (ICH Q10 concept).

新版中国GMP确立了实施质量目标最高管理层人员的责任，这一点来源于ICH Q10概念。

anization and personnel 组织机构和人员

SIMILARITIES 相似点:

People should be trained in their duties and in cGMPs, previously to perform their duties and continuously, by qualified personnel. A training programme should be in place to assure training is performed periodically, although US GMP does not specify it.

人员需要根据其GMP中的职责，上岗前进行培训，培训需要有连续性，并且由具有资质的人员实施。培训计划应到位以保证培训能够定期进行，但美国GMP没有涉及培训计划。

DIFFERENCES 差异点:

Main responsibilities of Head of Production, Quality Unit and Qualified person are described in EU and new Chinese GMPs. Nevertheless, new Chinese GMPs also identify the minimum training of the person in charge of production (degree in pharmacy), quality unit (degree in pharmacy or related), and qualified person (Bachelor degree in pharmacy or related). US GMP does not include any consideration about it.

在欧盟和中国新版GMP中明确了生产，质量主管和质量授权人的主要责任。然而，新版中国GMP 同时明确了人员的最低资质要求：生产负责人（药学或相关专业），质量单元（药学或相关专业）和质量授权人（药学或相关专业本科学位）。美国GMP没有上述要求。

EU GMPs and new Chinese GMPs are much more specific with Personnel hygienic, requiring an specific training programme. They also request periodical medical check to employees in direct contact with the product (at least one per year in new Chinese GMPs)

欧盟GMPs和中国新版GMP都特别关注了人员卫生，需要特别的培训内容。都要求进行直接接触产品的员工进行周期性体检（在中国新版GMP中规定至少每年1次）