【技术交流】中国新版， 欧盟和美国GMP比较概要（上）

New Chinese, EUand US GMPs comparative overview

中国新版，欧盟和美国GMP比较概要

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Date:24-Feb-2011

日期： 2011年2月24日

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

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1.      Quality Management 质量管理

SIMILARITIES相似点：

EU and newChinese GMPs set forth the requirement of establish a quality system, withtheir own quality objectives, applying all of requirements on safety, efficacyand quality control related with drug registration to the whole process of drugproduction. EU and new Chinese GMPs introduce the concepts of Quality Assurancein the same way. US GMPs does not establish the requirement of having a qualitysystem, but it can be understood with the whole reading of 21 CFR Parts210& 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 newChinese GMPs introduce clearly the Risk Management Approach according to ICH Q9concepts. Conversely, 21CFR does not mention these concepts which are muchnewer than last revision of US GMPs.

欧盟和中国新版GMP又再次重申了由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 Chiese GMPsidentifies the responsibility of top management personnel for the implementationof 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 betrained in their duties and in cGMPs, previously to perform their duties andcontinuously, by qualified personnel. A training programme should be in placeto assure training is performed periodically, although US GMP does not specifyit.

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 responsibilitiesof Head of Production, Quality Unit and Qualified person are described in EUand new Chinese GMPs. Nevertheless, new Chinese GMPs also identify the minimumtraining of the person in charge of production (degree in pharmacy), qualityunit (degree in pharmacy or related), and qualified person (Bachelor degree inpharmacy 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），质量部门（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 newChinese GMPs are much more specific with Personnel hygienic, requiring anspecific training programme. They also request periodical medical check toemployees in direct contact with the product (at least one per year in newChinese 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）。

Finally, US GMPis the only one requiring consultants’ qualification, their qualificationrecords (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 newChinese 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 permiteffective cleaning and maintenance in order to avoid cross-contamination, buildup of dust or dirt and, in general, any adverse effect on the quality ofproducts. They totally agree in the requirement of storage areas and auxiliaryareas.

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条例。而已图和设计必须专注于最小化产生错误内附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 theyagree in the general terms, some differences between them can be found, as thespecification of new Chinese GMP on the establishment of a minimum of 10psi ofdifferential pressure between clean areas and non-clean, or the requirement ofisolate the different packaging lines to avoid mix-ups (EU GMPs specifies“Different products should not be packaged in close proximity unless there isphysical segregation” and US GMPs “Prevention of mixups and cross-contaminationby 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砖头设计要至少保证最小10帕斯卡，对于隔离不同产品纯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预防混淆和交叉污染”。

For new ChineseGMPs a design of the plant in a logical sequence of manufacturing operationsconnections is not a requirement despite is supposes a cross-contaminationrisk.

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 GMPsestablishes the requirement of dispose sewage, trash, and other refuse in andfrom the building and immediate in a safe and sanitary manner, as well of theexistence 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

EU GMPs, US GMPsand new Chinese GMPs agree that Manufacturing equipment should be designed,located and maintained to suit its intended purpose, according the criteria toavoid risk of error or contamination, equipment should be cleaned accordingwritten procedures and that equipment maintenance and repair shall not affectthe product quality. Equipment should be used and cleaned according approvedSOPs.

欧盟GMP，美国GMP和新版中国GMP都要求和平设备需要根据规范按照预期的目的合理设计，安置和维护，以避免错误和污染的风险。设备需要根据建立的规程清洁。设备维护和维修不能影响产品质量，设备需要按照已批准的SOP使用和清洁。

DIFFERENCES 差异点：

New Chinese GMPsare much more explicit in some sections, for example, detailing SOPdistribution and withdrawal, the use of food grade lubricant when possible, theexistence of a maintenance programme, existence of specific cleaning methods,existence of equipment status identification or the existence of calibrationlabels. Moreover, new Chinese GMPs includes requirements on the water quality(at least use drinking water). These aspects are all inlucded in ICH Q7A (EUGMPs Part II )----Good Manufacturing Practice Guidance for ActivePharmaceutical Ingredients, but not in EU GMPs Part I or 21 CFR PARTS210&211.

新版中国GMP在某些方面更加详尽。例如，细化了SOP发布和撤销；尽可能使用食品级润滑油；要有维护计划，详细的清洁方法，设备状态标识或校验标签。此外，新版中国GMP包括了对用水质量的要求（至少使用饮用水）。这些方面都包含在了ICH Q7A（欧洲GMP第二部分）--原料药良好生产实践指南，但不包括在欧洲GMP第一部分或21CFR PARTS 210和211.

On the otherhand, US GMPs describe routine controls to be performed in computerized systemto assure that changes in master production and control records or otherrecords are instituted only by authorized personnel. Backup of computerizedsystem data is also required. Moreover, US GMPs includes the requirement of nonusing fiber-release filters in liquid filtration operations used in themanufacturing of injectables drug products.

在其它方面，美国GMP描述了对计算机系统的常规控制以保证在主生产和控制记录或者其他记录上的变更只能由授权人建立。同时要求计算机系统数据的备份。此外，美国GMP包括了对在注射剂产品生产时进行的液体过渡操作中应当使用无纤维脱落型过滤器的要求。

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