EUROPEAN COMMISSION
HEALTH AND CONSUMERS DIRECTORATE-GENERAL
Public Health and Risk Assessment
Medicinal products – quality, safety and efficacy
Brussels, 13 August 2014
Ares(2014)2674300
EudraLex
The Rules Governing Medicinal Products in the European Union
Volume 4
EU Guidelines for
Good Manufacturing Practice for
Medicinal Products for Human and Veterinary Use
Part 1
Chapter 3: Premises and Equipment
人药和兽药GMP指南 第1部分 第3章：厂房和设备
Legal basis for publishing the detailed guidelines: Article 47 of Directive 2001/83/EC on the Community code relating to medicinal products for human use and Article 51 of Directive 2001/82/EC on the Community code relating to veterinary medicinal products. This document provides guidance for the interpretation of the principles and guidelines of good manufacturing practice (GMP) for medicinal products as laid down in Directive 2003/94/EC for medicinal products for human use and Directive 91/412/EEC for veterinary use.
Status of the document: Revision.
文件状态：修订
Reasons for changes: The only change is to section 6 as part of the improved guidance on prevention of cross-contamination involving also Chapter 5.
变更原因：仅对第6部分进行了变更以提高对防止交叉污染的指南，该内容在第5章也有涉及。
Deadline for coming into operation: 1 March 2015.
生效时间：2015年3月1日
Commission Européenne, B-1049 Bruxelles / Europese Commissie, B-1049 Brussel – Belgium. Telephone: (32-2) 299 11 11
ER 3 PREMISES AND EQUIPMENT
Principle
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 minimise 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.
厂房和设备的位置、设计、结构、改建和维护保养应适合于所进行的操作。为了避免交叉污染、灰尘或污垢以及其它影响产品质量的因素，厂房和设备的而已及设计应使产生误差的危险减至最低限度，并易于有效的清洁和维护保养。
Premises 厂房
General 概述
3.1 Premises should be situated in an environment which, when considered together with measures to protect the manufacture, presents minimal risk of causing contamination of materials or products.
厂房的位置选择应考虑其环境能保证生产，同时又可使对物料或产品产生污染的危险减至最低。
3.2 Premises should be carefully maintained, ensuring that repair and maintenance operations do not present any hazard to the quality of products. They should be cleaned and, where applicable, disinfected according to detailed written procedures.
厂房的维护工作应细致，以确保在维修和维护保养操作中不会危及产品质量。应按照详细的书面操作规程对厂房进行清洁和必要的消毒。
3.3 Lighting, temperature, humidity and ventilation should be appropriate and such that they do not adversely affect, directly or indirectly, either the medicinal products during their manufacture and storage, or the accurate functioning of equipment.
厂房应有适当的照明、温度、湿度和通风条件。这些条件不得对生产和存贮中的药品质量或设备的精准操作产生直接或间接的影响。
3.4 Premises should be designed and equipped so as to afford maximum protection against the entry of insects or other animals.
厂房的设计和配置应能最大程度地防止昆虫和其它动物的侵入。
3.5 Steps should be taken in order to prevent the entry of unauthorised people. Production, storage and quality control areas should not be used as a right of way by personnel who do not work in them.
应采取措施防止未经准许的人员进入厂房。生产区、存贮区和质量控制区不得成为不在这些地方工作的人员通道。
Production Area 生产区域
3.6 Cross- contamination should be avoided for all products by appropriate design and operation of manufacturing facilities. The measures to prevent cross-contamination should be commensurate with the risks. Quality Risk Management principles should be used to assess and control the risks.
所有产品均应通过对生产设施适当的设计和操作来避免产生交叉污染。防止交叉污染的措施应与风险水平相适应。质量风险管理原则应应用于评估和控制这些风险。
Depending of the level of risk, it may be necessary to dedicate premises and equipment for manufacturing and/or packaging operations to control the risk presented by some medicinal products.
根据风险的水平，可能必须采用专用厂房和设备来生产和/或包装，以控制某些药品所具有的风险。
Dedicated facilities are required for manufacturing when a medicinal product presents a risk because :在生产具有风险的药品时是必须使用专用设施，因为
i. the risk cannot be adequately controlled by operational and/ or technical measures,
无法通过操作和/或技术措施对风险进行充分控制
ii. scientific data from the toxicological evaluation does not support a controllable risk (e.g. allergenic potential from highly sensitising materials such as beta lactams) or
毒理学科学数据无法支持对风险进行控制（例如，象?内酰胺一样的高致敏物料），或
iii. relevant residue limits, derived from the toxicological evaluation, cannot be satisfactorily determined by a validated analytical method.
通过毒理学评估所获得的相关残留限度不能采用经过验证的分析方法检测得到满意的结果
Further guidance can be found in Chapter 5 and in Annexes 2, 3, 4, 5 & 6.
更多指南可以在和5章和附录2、3、4、5和6找到。
3.7 Premises should preferably be laid out in such a way as to allow the production to take place in areas connected in a logical order corresponding to the sequence of the operations and to the requisite cleanliness levels.
厂房布局应使生产区域按操作顺序的逻辑关系相连，并与所要求的清洁水平相适应。
3.8 The adequacy of the working and in-process storage space should permit the orderly and logical positioning of equipment and materials so as to minimise the risk of confusion between different medicinal products or their components, to avoid cross-contamination and to minimise the risk of omission or wrong application of any of the manufacturing or control steps.
生产区域和在制品存贮空间应充分，使得设备和物料的定位有序且具有逻辑性，以将不同药品或其成分混淆的风险降至最低，避免交叉污染，将忽略或错误操作任何生产或控制步骤的风险降至最小。
3.9 Where starting and primary packaging materials, intermediate or bulk products are exposed to the environment, interior surfaces (walls, floors and ceilings) should be smooth, free from cracks and open joints, and should not shed particulate matter and should permit easy and effective cleaning and, if necessary, disinfection.
在起始物料和内包材、中间体或待包装成品暴露的环境中，（墙、地面和天花板的）内表面应光滑、无裂缝和断开的接头，表面材料应不起尘，易于进行有效的清洁，和必要时进行有效消毒。
3.10 Pipework, light fittings, ventilation points and other services should be designed and sited to avoid the creation of recesses which are difficult to clean. As far as possible, for maintenance purposes, they should be accessible from outside the manufacturing areas.
管道、照明、通风点和其它支持系统的设计和定位应避免难以清洁的凹形。为维护方便，应尽可能将其出入口设计在生产区域的外围。
3.11 Drains should be of adequate size, and have trapped gullies. Open channels should be avoided where possible, but if necessary, they should be shallow to facilitate cleaning and disinfection.
排水应具有足够的尺寸，应有截留井。应避免使用开放式通道排水。如果必须使用，则其设计应便于清洁和消毒。
3.12 Production areas should be effectively ventilated, with air control facilities (including temperature and, where necessary, humidity and filtration) appropriate both to the products handled, to the operations undertaken within them and to the external environment.
生产区域应配有充分的通风，配备空气控制设施（包括温度和，必要时湿度及过滤），适宜在该区域内所操作的产品以及适宜外部环境。
3.13 Weighing of starting materials usually should be carried out in a separate weighing room designed for such use.
起始物料的称重一般应在一个专门设计的独立称重间进行。
3.14 In cases where dust is generated (e.g. during sampling, weighing, mixing and processing operations, packaging of dry products), specific provisions should be taken to avoid cross contamination and facilitate cleaning.
如果操作会产尘（例如，干燥产品的取样、称重、混合和加工、包装），则需要采取特殊措施避免交叉污染，利于清洁。
3.15 Premises for the packaging of medicinal products should be specifically designed and laid out so as to avoid mix-ups or cross-contamination.
成品包装设施应进行特定设计，使其布局避免混淆和交叉污染。
3.16 Production areas should be well lit, particularly where visual on-line controls are carried out.
生产区域照明应良好，特别是如果需要进行目视在线控制检查时。
3.17 In-process controls may be carried out within the production area provided they do not carry any risk to production.
中控如果不会给生产带来风险，则可以在生产区域进行。
Storage Areas 存贮区域
3.18 Storage areas should be of sufficient capacity to allow orderly storage of the various categories of materials and products: starting and packaging materials, intermediate, bulk and finished products, products in quarantine, released, rejected, returned or recalled.
存贮区域应具有足够的空间，使得不同的物料和产品：起始物料、包材、中间体、散装药品和成品、待检成品、放行成品、拒收成品、退回成品和召回成品可以有序存放。
3.19 Storage areas should be designed or adapted to ensure good storage conditions. In particular, they should be clean and dry and maintained within acceptable temperature limits. Where special storage conditions are required (e.g. temperature, humidity) these should be provided, checked and monitored.
存贮区域设计应保证良好的存贮条件，特别应保持清洁干燥，温度维持在可接受的限度内。如果要求有特殊的存贮条件（例如，温度、湿度），则应提供相应的条件，并进行检查和监控。
3.20 Receiving and dispatch bays should protect materials and products from the weather. Reception areas should be designed and equipped to allow containers of incoming materials to be cleaned where necessary before storage.
收料区和发货区应能保护物料和产品免受恶劣天气影响。收料区设计和装配应使必要时可以对来料的包装在存贮前进行清洁。
3.21 Where quarantine status is ensured by storage in separate areas, these areas must be clearly marked and their access restricted to authorised personnel. Any system replacing the physical quarantine should give equivalent security.
如果待验状态是采用一个单独的区域来保证，则这些区域必须进行清楚的标识，其出入许可必须限于有授权的人员。所有用于物理隔离的系统均应有相应的保安措施。
3.22 There should normally be a separate sampling area for starting materials. If sampling is performed in the storage area, it should be conducted in such a way as to prevent contamination or cross-contamination.
起始物料一般应有单独的取样区域。如果在存贮区域取样，则取样操作应能防止污染和交叉污染。
3.23 Segregated areas should be provided for the storage of rejected, recalled or returned materials or products.
拒收、召回或退回物料和产品应有隔离区域。
3.24 Highly active materials or products should be stored in safe and secure areas.
高活性物料或产品应存放在安全并有保卫的区域。
3.25 Printed packaging materials are considered critical to the conformity of the medicinal product and special attention should be paid to the safe and secure storage of these materials.
印刷包材被认为是药品识别的关键物料，需要特别注意这类物料的安全及存贮保安。
Quality Control Areas
3.26 Normally, Quality Control laboratories should be separated from production areas. This is particularly important for laboratories for the control of biologicals, microbiologicals and radioisotopes, which should also be separated from each other.
质量控制实验室一般应与生产区分开。这对生物检定、微生物检定、放射性同位素检定的实验室尤为重要，它们应有各自独立的实验室。
3.27 Control laboratories should be designed to suit the operations to be carried out in them. Sufficient space should be given to avoid mix-ups and cross-contamination. There should be adequate suitable storage space for samples and records.
控制实验室应设计合理，便于检验操作。实验室应有充足的空间，以防止混淆和交叉污染。应有适当的样品贮存和记录存放的场所。
3.28 Separate rooms may be necessary to protect sensitive instruments from vibration, electrical interference, humidity, etc.
为保护灵敏仪器设备免受振动、电子干扰和湿 度等因素的影响，必要时应有各自单独的操作间。
3.29 Special requirements are needed in laboratories handling particular substances, such as biological or radioactive samples.
从事特殊物品（生物制品或放射性样品）检验的实验室应有特殊的要求。
Ancillary Areas 辅助区域
3.30 Rest and refreshment rooms should be separate from other areas.
休息和茶点室应与其它区域分开。
3.31 Facilities for changing clothes and for washing and toilet purposes should be easily accessible and appropriate for the number of users. Toilets should not directly communicate with production or storage areas.
更衣室、清洁间和卫生间应便于人员进入，并与使用者的数目相适应。卫生间不能与生产区或贮存区直接相连。
3.32 Maintenance workshops should as far as possible be separated from production areas. Whenever parts and tools are stored in the production area, they should be kept in rooms or lockers reserved for that use.
维修间应尽可能地与生产区分开。在生产区内存放的零配件和工具，应保存在专用的房间内或带锁的小柜中。
3.33 Animal houses should be well isolated from other areas, with separate entrance (animal access) and air handling facilities.
动物房间应与其它区域严格分开，并有专门入口（动物进口）和空气处理设施。
Equipment 设备
3.34 Manufacturing equipment should be designed, located and maintained to suit its intended purpose.
生产设备的设计、定位和维护应适合于其既定用途。
3.35 Repair and maintenance operations should not present any hazard to the quality of the products.
维修和维护保养操作不应危及产品质量。
3.36 Manufacturing equipment should be designed so that it can be easily and thoroughly cleaned. It should be cleaned according to detailed and written procedures and stored only in a clean and dry condition.
生产设备的设计应易于彻底清洁。设备清洁应遵循详细的书面程序。设备应存放在清洁干燥的环境中。
3.37 Washing and cleaning equipment should be chosen and used in order not to be a source of contamination.
选用的洗涤和清洁设备不应成为污染源。
3.38 Equipment should be installed in such a way as to prevent any risk of error or of contamination.
设备的安装不应发生差错或产生污染。
3.39 Production equipment should not present any hazard to products. Parts of production equipment that come into contact with the product must not be reactive, additive or absorptive to such an extent that it will affect the quality of the product and thus present any hazard.
使用的生产设备不应对产品质量有不良影响。设备中与产品直接接触的部分不应与产品发生化学反应、加成作用或吸附作用以至影响产品质量，发生任何质量事故。
3.40 Balances and measuring equipment of an appropriate range and precision should be available for production and control operations.
衡器和测量设备的范围和精密度应满足生产和控制的要求。
3.41 Measuring, weighing, recording and control equipment should be calibrated and checked at defined intervals by appropriate methods. Adequate records of such tests should be maintained.
对于测量、称量、记录和控制设备，应采用合适的方法在规定时间内里德校验和检查，并保存这些检测的记录。
3.42 Fixed pipework should be clearly labelled to indicate the contents and, where applicable, the direction of flow.
固定的管线应清楚地标识其内容物和流向。
3.43 Distilled, deionised and, where appropriate, other water pipes should be sanitised according to written procedures that detail the action limits for microbiological contamination and the measures to be taken.
应根据书面程序对蒸馏水管、去离子水管和其它水管进行清洁。书面规程应描述微生物污染的超标限度和应采取的措施。
3.44 Defective equipment should, if possible, be removed from production and quality control areas, or at least be clearly labelled as defective.
不合格的设备应尽可能的搬离生产区和质量控制区，或至少应有醒目的不合格标志。
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