中国新版GMP与欧盟、美国GMP比较概要

GMP对比

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)

GMP对比

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。

2. Organization 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）

GMP对比

Finally, US GMP is the only one requiring consultants’ qualification. Their qualification records (curriculums) should be retained.

只有美国GMP需要对咨询师的资质有要求。资质记录（简历）需要保留。

3. Facility and utilities 厂房和设施

SIMILARITIES 相似点:

EU, US and new Chinese GMPs agree that Premises and equipment must be located, designed, constructed, adapted and maintained to suit the operations to be carried out. Their layout and design must aim to minimize the risk of errors and permit effective cleaning and maintenance in order to avoid cross-contamination, build up of dust or dirt and, in general, any adverse effect on the quality of products. They totally agree in the requirement of storage areas and auxiliary areas.

欧盟，美国和中国新版GMP都要求厂房和设备的安置，设计，建筑材料，配置和维护需要与相应的操作相符合。布局图和设计必须专注于最小化产生错误风险并易于有效清洁和维护避免交叉污染。积累灰尘或者污物——即避免任何不利于产品质量的有害影响。这也同样适用于存储区域和辅助区域。

DIFFERENCES 差异点:

Although they agree in the general terms, some differences between them can be found, as the specification of new Chinese GMP on the establishment of a minimum of 10 psi of differential pressure between clean areas and non-clean, or the requirement of isolate the different packaging lines to avoid mix-ups (EU GMPs specifies “Different products should not be packaged in close proximity unless there is physical segregation” and US GMPs “Prevention of mixups and cross-contamination by physical or spatial separation from operations on other drug products”).

虽然他们在通则方面都相同，但是还是存在一些差异点，例如新版中国GMP 在洁净区和非洁净区压差设计要至少保证最小10帕斯卡，对于隔离不同产品线避免混淆的要求也有不同之处，欧盟GMP规定“不同产品间不能靠近包装，除非有物理隔离”同样，美国GMP规定了“通过与其他药品生产操作的物理或者空间隔离预防混淆和交叉污染”

For new Chinese GMPs a design of the plant in a logical sequence of manufacturing operations connections is not a requirement despite it supposes a cross-contamination risk.

新版中国GMP 没有对厂房设计需要按照工艺操作逻辑路线合理安排的要求，尽管这是可能带来交叉污染风险的因素之一。

Finally, US GMPs establishes the requirement of dispose sewage, trash, and other refuse in and from the building and immediate in a safe and sanitary manner, as well of the existence of written procedures for installation sanitization.

最后，美国GMP建立了对污水处理，垃圾和其他废物的处理要求。必须立即根据建立的卫生处理规程用安全和清洁的方式进行管理。

4. Equipment 设备

SIMILARITIES 相似点:

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