EUROPEAN COMMISSION
广州流花湖公园锤炼是什么意思欧盟委员会
HEALTH AND CONSUMERS DIRECTORATE-GENERAL
脸晒黑了最快恢复办法健康与消费者总司
Health Systems and Products
健康体系与产品
Medicinal Products - Quality, safety and efficacy
药品-质量、安全性与有效性
Brusls, 13 August 2014
布鲁塞尔，2014年08月13日
Ares(2014)2674300
EudraLex
The Rules Governing Medicinal Products in the European Union
欧盟药品管理法规
Volume 4
第四卷
EU Guidelines for
欧盟指南
Good Manufacturing Practice for Medicinal Products for Human and Veterinary U
人用与兽用药品生产质量管理规范
Chapter 3
第三章
Premis and Equipment
厂房与设备
Legal basis for publishing the detailed guidelines: Article 47 of Directive 2001/83/EC on the Community code relating to medicinal products for human u 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 u and Directive 91/412/EEC for veterinary u.
发布详细指南的法律依据：欧盟法规有关的人用药品的第2001/83/EC 法令的第47款。本文件提供指
南来解释在第2003/94/EC 号法令下人用药品以及第91/412/EEC 号法令下兽药药品生产管理规范(GMP)的原则与指导。 Status of the document: Revision.
文件状态：修订
Reasons for changes: The only change is to ction 6 as part of the improved guidance on prevention of cross-contamination involving also Chapter 5.
变更原因：仅仅变更了第6节作为同样在第5章所涉及到的预防交叉污染指南部分的改进。
Deadline for coming into operation: 1 March 2015.
实施日期：2015年03月01日
Principle
基本原则
Premis 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 minimi 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 adver effect on the quality of products.
厂房与设备的选址、设计、建造、改造及维护必须适用于所实施的操作。为避免交叉污染，积灰以及对产品质量不良影响，厂房和设备的设计和布局必须能最大限度降低发生差错的风险，有便于有效清洁和维护。
Premis
厂房
General
总则
3.1 Premis should be situated in an environment which, when considered together with measures to protect the
manufacture, prents minimal risk of causing contamination of materials or products.
应当根据厂房及制造保护措施综合考虑选址问题，厂房所处的环境应能使物料或产品遭受污染的风险最小。
3.2 Premis should be carefully maintained, ensuring that repair and maintenance operations do not prent any hazard
to the quality of products. They should be cleaned and, where applicable, disinfected according to detailed written procedures.
厂房应当仔细维护，确保维修活动无影响产品的质量危险。厂房应按详细的书面规程进行清洁，如果需要，进行消毒。
3.3 Lighting, temperature, humidity and ventilation should be appropriate and such that they do not adverly affect,
directly or indirectly, either the medicinal products during their manufacture and storage, or the accurate functioning of equipment.
厂房应当有适当的照明、温湿度与通风，这些条件不直接或间接不良影响药品制造与贮存期间质量，或设备准确的功能。
3.4 Premis should be designed and equipped so as to afford maximum protection against the entry of incts or other
animals.
厂房的设计与装备应能最大程度防止昆虫或其它动物的进入。
3.5 Steps should be taken in order to prevent the entry of unauthorid people. Production, storage and quality control
areas should not be ud as a right of way by personnel who do not work in them.
应当采取适当措施，防止未经批准的人员进入。生产、贮存和质量控制区不应当作为非本区工作人员的通道。
Production Area
生产区
3.6 Cross-contamination should be prevented 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 ud to asss and control the risks.
所有的产品应当通过恰当的设计与制造设施操作来避免交叉污染。预防交叉污染的措施应当与风险一致。
应当那个使用质量风险管理基本原则来评估与控制风险。
Depending of the level of risk, it may be necessary to dedicate premis and equipment for manufacturing and/or packaging operations to control the risk prented 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 prents a risk becau:
当药品呈现下列风险，制造需要用专用设施：
i. the risk cannot be adequately controlled by operational and/ or technical measures,
该风险不能通过操作，和/或，技术措施足够控制，
ii. scientific data from the toxicological evaluation does not support a controllable risk (e.g. allergenic potential from highly nsitising 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β-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 Premis 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 quence of the operations and to the requisite cleanliness levels.
厂房应当最好按生产工艺流程及相应洁净级别要求合理布局。
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 minimi the risk of confusion between different medicinal products or their components, to avoid cross-contamination and to minimi the risk of omission or wrong application of any of the manufacturing or control steps.
工作区和中间物料存贮区应有足够的空间，以有序地存放设备和物料，避免不同药品或组分混淆、避免交叉污染、避免制造或质量控制操作发生遗漏或差错。
3.9 Where starting and primary packaging materials, intermediate or bulk products are expod 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.
起始物料、内包装材料、中间体或半成品暴露环境的内表面(墙壁、地面、天棚)应当平整光滑、无裂缝、接口严密、无颗粒物脱落，便于有效清洁和必要时进行消毒。
3.10 Pipework, light fittings, ventilation points and other rvices should be designed and sited to avoid the creation of
recess which are difficult to clean. As far as possible, for maintenance purpos, they should be accessible from outside the manufacturing areas.
管道、照明设施、送风口和其它公用设施的设计和安装应避免出现难以清洁的凹陷部位。应尽可能做到在制造区外部对它们进行维护。
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.
排水设施应大小适宜，安装防止倒灌的装置。应尽可能避免明沟，不可避免时，明沟宜浅，以方便清洁和消毒。
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.
应根据所处理的产品、生产操作要求及外部环境状况配置空调净化系统，使生产区有效的通风(包括，温度控制、必要的湿度控制和空气净化过滤)。
种菜赚钱吗3.13 Weighing of starting materials usually should be carried out in a parate weighing room designed for such u.
起始物料的称量通常应在专门设计的称量室内进行。
3.14 In cas 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.
在产尘区域(如，取样、称量、混合与加工、干燥产品包装)，应采取专门的措施避免交叉污染并便于清洁。
3.15 Premis for the packaging of medicinal products should be specifically designed and laid out so as to avoid mix-
ups or cross-contamination.
用于药品包装的厂房应专门设计和布局，以避免混淆或交叉污染。
3.16 Production areas should be well lit, particularly where visual on-line controls are carried out.
生产区应有足够的照明，特别是产品在线目检区。
3.17 In-process controls may be carried out within the production area provided they do not carry any risk to production.
在生产区域内可进行中间控制，但不得给生产带来风险。
Storage Areas
储存区
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, relead, rejected, returned or recalled.
储存区应有足够的空间，以便有序地存放各类物料和产品：起始物料、包装材料、中间体、半成品与成品，以及待验、合格、不合格、退回或召回的产品等。
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) the 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。
人心向善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.
收发与发放区应能保护物料与产品免受外界气候的影响。接收区的设计和装备配置应确保进货的物料容器在进入储存前可进行必要的清洁。
3.21 Where quarantine status is ensured by storage in parate areas, the areas must be clearly marked and their access
restricted to authorid personnel. Any system replacing the physical quarantine should give equivalent curity.
当用隔离区域保证待检状态，其应有醒目标识，且只限于经批准的人员出入。如果采用其它方法替代物理待检，应具有同等的安全性。
3.22 There should normally be a parate 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.
通常应有隔离的起始物料取样区。如在储存区取样，则应以能防止污染或交叉污染的方式进行。
3.23 Segregated areas should be provided for the storage of rejected, recalled or returned materials or products.
不合格，退回或召回的物料或产品应隔离存放。
3.24 Highly active materials or products should be stored in safe and cure areas.
高活性物料或产品应存放在安全的区域内。
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 cure storage of the materials.
印刷好的包装材料是确保药品标识正确的关键，应特别注意安全贮存。
Quality Control Areas
质量控制区
3.26 Normally, Quality Control laboratories should be parated from production areas. This is partic
ularly important for
laboratories for the control of biologicals, microbiologicals and radioisotopes, which should also be parated from each other.
质量控制实验室通常应与生产区隔离。这一点对于生物、微生物和放射性同位素控制实验室非常重要，其还应彼此分开。
社交媒体英文
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.
实验室设计应确保其适用于预期的操作。实验室应有足够的空间以避免混淆和交叉污染，同时应有足够的适合样品和记录保存空间。
3.28 Separate rooms may be necessary to protect nsitive instruments from vibration, electrical interference, humidity,
etc.
必要时，应设置专门的仪器室，使高灵敏仪器免受电压震动，电磁，潮湿等因素的干扰。
3.29 Special requirements are needed in laboratories handling particular substances, such as biological or radioactive
诗水蛇山神庙
samples.
在实验室中处理特殊物质的特殊要求，如生物或放射性样品。
Ancillary Areas
辅助区
3.30 Rest and refreshment rooms should be parate from other areas.
休息室/餐饮室应与其它区域分开。
3.31 Facilities for changing clothes and for washing and toilet purpos should be easily accessible and appropriate for
the number of urs. Toilets should not directly communicate with production or storage areas.
更衣室、盥洗室与卫生间应方便人员出入，并与使用人数相适应。卫生间不得与生产区或储存区直接相连。
3.32 Maintenance workshops should as far as possible be parated from production areas. Whenever parts and tools are
stored in the production area, they should be kept in rooms or lockers rerved for that u.
维修间应尽可能与生产区分开。存放在生产区内的维修用备件与工具，应放置在专门的房间或上锁的工具柜中。
交友名言名句大全
3.33 Animal hous should be well isolated from other areas, with parate entrance (animal access) and air handling
facilities.
动物房应与其它区域严格分开，并设有专门(动物)的通道以及空气处理设施。
Equipment
设备
3.34 Manufacturing equipment should be designed, located and maintained to suit its intended purpo.
制造设备的设计、选址、维护应适用于预定用途。
3.35 Repair and maintenance operations should not prent any hazard to the quality of the products.
设备的维修和维护不应危害产品质量。
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.
制造设备的设计应便于彻底清洁。应按书面的详细规程清洁设备，并在清洁、干燥的条件下存放。
3.37 Washing and cleaning equipment should be chon and ud in order not to be a source of contamination.
应选择并使用清洗、清洁设备方式，以避免其成为污染源。
3.38 Equipment should be installed in such a way as to prevent any risk of error or of contamination.
设备的安装方式应有利于防止任何差错或污染。
3.39 Production equipment should not prent 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 prent any hazard.
生产设备不应对产品有任何危害。与产品接触的部件必须与药品不发生化学反应、填加或吸附物质而影响产品质量，并造成任何危害。
3.40 Balances and measuring equipment of an appropriate range and precision should be available for production and
control operations.
用于药品的生产和控制的衡器和量具应具有适当量程和精密度。
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.
应按照适当的方法定期对测量、称重、记录和控制设备进行校准与核实，并保存相关记录。
3.42 Fixed pipework should be clearly labelled to indicate the contents and, where applicable, the direction of flow.
固定管线应标明内容物，必要时，还应标明流向。
3.43 Distilled, deionid and, where appropriate, other water pipes should be sanitid according to written procedures
that detail the action limits for microbiological contamination and the measures to be taken.
应按照书面规程消毒蒸馏水、去离子水管道，以及其它供水管路(必要时)。书面规程中，应详细规定微生物污染的纠偏限度及应采取的措施。
