欧盟GMP中英文对照
European Union
药品生产质量管理规范GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS
目录
第一章质量管理
CHAPTER 1: QUALITY MANAGEMENT
原则............................................................ ..................................................... ............ (5)
Principle (5)
质量保证................................................................... .............. . (5)
Quality Assurance (5)
药品生产质量管理规范(GMP) (7)
Good Manufacturing Practice for Medicinal Products (7)
质量控制(QC) (9)
Quality Control....................... . (9)
产品质量回顾....................... ....................... (10)
第二章人员
CHAPTER 2: PERSONNEL...................................................................................... .. (11)
原则 (11)
Principle (11)
通则 (12)
General...................................................................................................................... . (12)
关键人员................................................................................................................... . (12)
Key Personnel (12)
培训 (12)
Training..................................................................................................................... . (15)
人员卫生 (16)
Personnel Hygiene (16)
第三章厂房和设备
CHAPTER 3: PREMISES AND EQUIPMENT................................................................ .. (18)
原则 (18)
Principle (18)
厂房 (18)
Premises (18)
通则 (18)
General (18)
生产区 (19)
Production Area (19)
贮存区 (21)
Storage Area (21)
Quality Control Area (22)
附助区 (22)
Ancillary Areas (22)
设备 (23)
Equipment (23)
第四章文件
CHAPTER 4: DOCUMENTATION (24)
原则 (24)
Principle (24)
通则 (25)
General (25)
文件要求 (27)
Documents Required (27)
Specifications (27)
Specifications for starting and packaging materials (27)
Specifications for Intermediate and Bulk Products (27)
Specifications for Finished Products (28)
Manufacturing Formulae and Processing Instructions (28)
Packaging Instructions (30)
Batch Processing Records (31)
Batch Packaging Records. (32)
Procedures and Records........................................................................................ .. (33)
Receipt (34)
Sampling (34)
Testing (35)
Other (35)
第五章生产
CHAPTER 5: PRODUCTION......................................... ........ (36)
原则........................................ . (36)
Principle (36)
通则........................................ . (36)
General (36)
生产过程中对交叉污染的预防 (39)
Prevention of Cross-contamination in Production (39)
Validation................................. . (40)
原料........................................ . (41)
Starting Materials..................... . (41)
生产操作：中间产品和待包装产品 (42)
Processing Operations: Intermediate and Bulk Products (42)
包装材料........................................ . (43)
Packaging Materials.......................... . (43)
包装操作........................................ . (44)
Packaging Operations........................ . (44)
成品........................................ . (46)
Finished Products..................... . (46)
不合格、回收料和退货物料 (46)
Rejected, Recovered and Returned Materials (46)
第六章质量控制
CHAPTER 6: QUALITY CONTROL (48)
原则........................................ . (48)
Principle................................... . (48)
通则........................................ . (48)
General... .. (48)
质量控制实验室规范 (49)
Good Quality Control Laboratory Practice (49)
Documentation (49)
Sampling................................... (50)
Testing... .. (52)
销售产品的稳定性考察 (54)
第七章委托生产与委托检验
CHAPTER 7: CONTRACT MANUFACTURE AND ANALYSIS (55)
原则........................................ . (55)
Principle................................... . (55)
通则........................................ . (56)
General..................................... . (56)
委托方.................................... . (56)
受托方.................................... (57)
The Contract Acceptor.............. (57)
合同........................................ . (58)
The Contract............................. (58)
第八章投诉与召回
CHAPTER 8: COMPLAINTS AND PRODUCT RECALL (59)
原则........................................ . (59)
Principle.................................... . (59)
投诉........................................ . (59)
Complaints................................ . (59)
召回 (60)
Recalls (60)
第九章自查
CHAPTER 9: SELF INSPECTION (61)
原则 (61)
Principle (61)
附件8 原辅料和包装材料的取样
ANNEX8 SAMPLING OF STARTING AND PACKAGING MATERIALS (63)
原则 (63)
Principle (63)
人员 (63)
Personnel (63)
原辅料 (63)
Starting materials (64)
包装材料 (65)
Packaging material (65)
第一章质量管理
CHAPTER 1 QUALITY MANAGEMENT
Principle
原则
生产许可证持有厂家只能生产医药产品，以确保药品符合其预期的使用目的，符合销售许可证的要求，并不因药品安全性、质量或药效方面的问题而给患者带来风险。达到这一质量目标是高层管理者的责任，同时也需要公司各部门、各层次的职员以及公司的供应商和销售商的参与并承担义务。为了确保达到该质量目标，必须全面设计并正确贯彻实施包括GMP与质量控制(QC)在内的质量保证(QA)体系。该体系应用文件明文规定并对其有效性加以监控。质量保证体系的所有部门都必须充分配备胜任的人员，适宜足够的厂房、设备及设施。与此同时，生产许可证持有者及受权人员具有另外的法律责任。
The holder of a Manufacturing Authorisation must manufacture medicinal products so as to ensure that they are fit for their intended use, comply with the requirements of the Marketing Authorisation and do not place patients at risk due to inadequate safety, quality or efficacy. The attainment of this quality objective is the responsibility of senior management and requires the participation and commitment by staff in many different departments and at all levels within the company, by the company’s suppliers and by the distributors. To achieve the quality objective reliably there must be a comprehensively designed and correctly implemented system of Quality Assurance incorporating Good Manufacturing Practice and thus Quality Control. It should be fully documented and its effectiveness monitored. All parts of the Quality Assurance system should be adequately resourced with competent personnel, and suitable and sufficient premises, equipment and facilities. There are additional legal responsibilities for the holder of the Manufacturing Authorisation and for the Qualified Person(s).
1.1.质量保证、GMP和质量控制的基本概念是内在相互联系的。这里叙述的主要目的是强调它们之间的关系以及药品生产和控制中的重要性。
1.1.The basic concepts of Quality Assurance, Good Manufacturing Practice and Quality Control are inter-related. They are described here in order to emphasise their relationships and their fundamental importance to the production and control of medicinal products.
Quality Assurance
质量保证
1.2.Quality Assurance is a wide ranging concept which covers all matters which individually or collectively influence the quality of a product. It is the sum total of the organized arrangements made with the object of ensuring that medicinal products are of the quality required for their intended use. Quality Assurance therefore incorporates Good Manufacturing Practice plus other factors outside the scope of this Guide.
1.2.质量保证是一个宽泛的概念，它包括影响产品质量的所有问题，是确保药品质量符合预期使用目的而进行组织管理的总和。因此质量保证是由GMP 本规范之外的其他因素所组成。
The system of Quality Assurance appropriate for the manufacture of medicinal products should ensure that:
质量保证体系对于药品的生产而言，应保证：
i. medicinal products are designed and developed in a way that takes account of the requirements of Good Manufacturing Practice and Good Laboratory Practice;
i.药品的设计与开发应按照GMP和GLP的要求进行；
ii. production and control operations are clearly specified and Good Manufacturing Practice adopted;
ii.生产和控制操作应有明确规定，并采用GMP；
iii. managerial responsibilities are clearly specified;
iii.明确规定管理职责；
iv. arrangements are made for the manufacture, supply and use of the correct starting and packaging materials;
iv.安排生产、供应和使用正确的原、辅、包材料；
v. all necessary controls on intermediate products, and any other in-process controls and validations are carried out;
v.对中间产品进行必要的控制、进行其他任何过程控制和验证；
vi. the finished product is correctly processed and checked, according to the defined procedures;
vi.按照规定的程序，正确地加工与核查成品；
vii. medicinal products are not sold or supplied before a Qualified Person has certified that each production batch has been produced and controlled in accordance with the requirements of the Marketing Authorisation and any other regulations relevant to the production, control and release of medicinal products;
vii.在受权人确认批产品按照销售许可证和其他与药品生产、检验和释放有关
的法规要求进行生产和质量控制，并签发合格证之前，药品不得销售或供应；viii. satisfactory arrangements exist to ensure, as far as possible, that the medicinal products are stored, distributed and subsequently handled so that quality is maintained throughout their shelf life;
viii.尽可能对药品贮存、销售及随后的处理做出满意的安排，以保证药品在货架寿命期内的质量；
ix. there is a procedure for Self-Inspection and/or quality audit which regularly appraises the effectiveness and applicability of the Quality Assurance system.
ix.建立自检和/或质量审计程序，定期对质量保证体系的有效性和适用性进行评价。
Good Manufacturing Practice for Medicinal Products (GMP)
药品生产质量管理规范(GMP)
1.3 Good Manufacturing Practice is that part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the Marketing Authorisation or product specification.
1.3 GMP是质量保证的一部分，它确保药品始终按照适合于其使用目的的质
量标准进行生产和控制，并符合销售许可证的要求。
Good Manufacturing Practice is concerned with both production and quality control. The basic requirements of GMP are that:
GMP涉及生产和质量控制，其基本要求如下：
i. all manufacturing processes are clearly defined, systematically reviewed in the light of experience and shown to be capable of consistently manufacturing medicinal products of the required quality and complying with their specifications;
i.所有生产工艺应有明确规定，根据经验进行系统的审核，并证明能够始终如一地生产出符合质量标准的药品。
ii. critical steps of manufacturing processes and significant changes to the process are validated;
ii.应对生产工艺的关键步骤和工艺的重要变更进行验证。
iii. all necessary facilities for GMP are provided including:
iii.提供所有GMP必需的设施，包括：
a. appropriately qualified and trained personnel;
a.资历合格并经过培训的人员；
b. adequate premises and space;
b.适宜的厂房和空间；
c. suitable equipment and services;
c.合适的设备及配套设施；
d. correct materials, containers and labels;
d.正确的物料、容器和标签；
e. approved procedures and instructions;
经批准的程序和指令；
f. suitable storage and transport;
f.合适的贮存设施和运输设备。
iv. instructions and procedures are written in an instructional form in clear and unambiguous language, specifically applicable to the facilities provided;
iv.指令和程序应使用清楚明了的语言，并适用于所提供的设施。
v. operators are trained to carry out procedures correctly;
v.操作者应经过培训，以便按正确地按照程序进行操作。
vi. records are made, manually and/or by recording instruments, during manufacture which demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the product was as expected. Any significant deviations are fully recorded and investigated;
vi.生产过程中采用手工和/或记录仪填写记录，以证明已完成的所有生产步
骤是按照确定的程序和指令要求进行的，产品达到预期的质量和数量。任何
重要偏差都应详细记录和调查。
vii. records of manufacture including distribution which enable the complete history of a batch to be traced, are retained in a comprehensible and accessible form;
vii.采用合适的方式保存生产记录（包括销售记录），以便追溯各批产品的完整历史。
viii. the distribution (wholesaling) of the products minimises any risk to their quality;
viii.应将产品销售（批发）中影响质量的风险减至最低限度。
ix. a system is available to recall any batch of product, from sale or supply;
ix.建立从销售或供应渠道收回任何一批产品的系统。
x. complaints about marketed products are examined, the causes of quality defects investigated and appropriate measures taken in respect of the defective products and to prevent reoccurrence.
x.了解上市产品的用户投拆，调查质量缺陷的原因，并采取的相应的整改措施，以避免再次发生。
Quality Control
质量控制(QC)
1.4 Quality Control is that part of Good Manufacturing Practice which is concerned with sampling, specifications and testing, and with the organisation, documentation and release procedures which ensure that the necessary and relevant tests are actually carried out and that materials are not released for use, nor products released for sale or supply, until their quality has been judged to be satisfactory.
1.4质量控制是GMP的一部分，它涉及取样、质量标准和质量检验、机构、
文件和放行程序，以确保进行必要的相关检验，在判定质量符合要求之前，
物料不得使用，产品不得销售或供应。
The basic requirements of Quality Control are that:
质量控制的基本要求如下：
i. adequate facilities, trained personnel and approved procedures are available for sampling, inspecting and testing starting materials, packaging materials, intermediate, bulk, and finished products, and where appropriate for monitoring environmental conditions for GMP purposes; i.有适宜的设施、经过培训的人员和批准的程序，以便对原辅料、包装材料、中间产品、待包装品和成品进行取样、检查、测试以及必要时按照GMP要求对环境进行监测。
ii. samples of starting materials, packaging materials, intermediate products, bulk products and finished products are taken by personnel and by methods approved by Quality Control;
ii.由质量部门批准的人员并使用已批准的方法对原辅料、包装材料、中间产
品、待包装品和成品进行取样。
iii. test methods are validated;
iii.对检验方法进行验证。
iv. records are made, manually and/or by recording instruments, which demonstrate that all the required sampling, inspecting and testing procedures were actually carried out. Any deviations are fully recorded and investigated;
iv.采用手工和/或记录仪进行记录，以证明规定的取样、检查和测试程序均
已完成。详细记录出现的任何偏差，并进行调查。
v. the finished products contain active ingredients complying with the qualitative and quantitative composition of the Marketing Authorisation, are of the purity required, and are enclosed within their proper containers and correctly labelled;
成品应含有符合销售许可证规定的定性、定量要求的活性成分，应具有规定的纯度，包装在合适容器中，并正确加贴标签。
vi. records are made of the results of inspection and that testing of materials, intermediate, bulk, and finished products is formally assessed against specification. Product assessment includes a review and evaluation of relevant production documentation and an assessment of deviations from specified procedures;
vi.记录应包括检查结果以及物料、中间产品、待包装品和成品依照质量标准
进行检验的评价结果。产品评价包括对有关生产文件的审核与评价以及对偏
离规定程序的偏差的评价。
vii. no batch of product is released for sale or supply prior to certification by a Qualified Person that it is in accordance with the requirements of the Marketing Authorisation;
vii.任何一批产品在未经受权人按照销售许可证的要求审核并签发合格证之前，不得放行销售或供应。
viii. sufficient reference samples of starting materials and products are retained to permit future examination of the product if necessary and that the product is retained in its final pack unless exceptionally large packs are produced.
viii.原料有充足的对照品，产品应保留以便用于将来必须的产品检验，除产品的大包装外，产品保留最终包装形式。
1.5.产品质量回顾
应对药品定期进行质量回顾以证明所用工艺的始终一致性，并重点反映出变化趋势。产品质量回顾一般情况下每年进行一次，并形成文件。内容至少应包括：
(1) 对产品中所使用的原辅料进行质量回顾，特别是那些由新供应商提供的原辅料。
(2) 对关键的过程控制和成品的检验结果进行质量回顾。
(3) 对所有不符合质量标准的批次进行回顾。
(4) 对所有关键性的偏差或不符合项以及与之相关的调查进行回顾。
(5) 对所有工艺或检验方法的变更进行回顾。
(6) 对销售许可证变更内容的申报/批准/拒绝批准的情况进行回顾，包括第三国申报的资料。
(7) 对稳定性监测结果进行回顾。
(8) 对所有与质量相关的退货、投诉、召回进行回顾，包括那些只出口的药品。
(9) 对以前整改措施的适合性进行回顾。
(10)对于新的销售许可证，则对其执行情况进行回顾。
(11)已进行验证的设备清单和再验证的日期。
生产厂家和销售许可证的持有者应对产品质量回顾的结果进行评价，对于差异，应评价其是否采取整改措施或是否应进行再验证。进行整改的原因应形成文件。对于已同意的整改措施应通过有效的方法适时完成。产品质量回顾可根据产品类型进行相应的分类，例如：固体制剂、液体制剂、无菌产品等。
当工艺发生重大变更和/或对工艺进行了再验证时，应将一个批次或多个批次的产品列入稳定性考察计划。无论如何，每年应对每一产品的一个批次进行稳定性考察；如果某产品每年的生产批次不足一批，那么所生产的每一批产品都应列入稳定性考察计划。
当生产厂家与销售许可证的持有者不是同一单位时，应签订技术协议详细说明双方在生产和产品质量回顾方面各自相应的职责。受权人应确保产品质量回顾适时进行，并且确保其结果的准确性。
第二章人员
CHAPTER 2 PERSONNEL
Principle
原则
The establishment and maintenance of a satisfactory system of quality assurance and the correct manufacture of medicinal products relies upon people. For this reason there must be sufficient qualified personnel to carry out all the tasks which are the responsibility of the manufacturer. Individual responsibilities should be clearly understood by the individuals and recorded. All personnel should be aware of the principles of Good Manufacturing Practice that
affect them and receive initial and continuing training, including hygiene instructions, relevant to their needs.
良好的质量保证体系的建立和保持以及药品的正确生产都需要依靠人来完
成，因此必须有足够的高素质人员来承担企业的全部工作和责任。应清楚地了解并记录各自的职责。所有人员均应了解与其有关的GMP的原则，并接受其工作所需要的初步培训和继续培训，其中包括卫生学知识的培训。General
通则
2.1 The manufacturer should have an adequate number of personnel with the necessary qualifications and practical experience. The responsibilities placed on any one individual should not be so extensive as to present any risk to quality.
2.1.生产厂应有足够数量的具有资格和实践经验的人员，任何一个人所担负
的责任不应太多，以免出现质量隐患。
2.2 The manufacturer must have an organisation chart. People in responsible positions should have specific duties recorded in written job descriptions and adequate authority to carry out their responsibilities. Their duties may be delegated to designated deputies of a satisfactory qualification level. There should be no gaps or unexplained overlaps in the responsibilities of those personnel concerned with the application of Good Manufacturing Practice.
2.2.生产厂应有组织机图，重要岗位的负责人应有明确的书面岗位职责，并有权履行其职责。他们职责可以委派给具有满意资历水平的副职人员代理。执行GMP的有关人员的职责，不应有空缺或重叠。
Key Personnel
关键人员
2.3 Key Personnel include the head of Production, the head of Quality Control, and if at least one of these persons is not responsible for the duties described in Article 22 of Directive
75/319/EEC, the Qualified Person(s) designated for the purpose. Normally key posts should be occupied by full-time personnel. The heads of Production and Quality Control must be independent from each other. In large organisations, it may be necessary to delegate some of the functions listed in 2.5, 2.6 and 2.7.
2.3.关键人员包括生产部门负责人和质量控制部门负责人，如果其中至少一人不负责75/319/EEC《指南》第22条款中所描述的职责，则应指定受权人（QP）负责。通常，关键岗位人员应为全职人员。生产部门和质量控制部门的负责人不能兼任。在较大的生产厂里，有必要将2.5、2.6、2.7条所列的
一些职能委派给代理人。
2.4 The duties of the Qualified Person(s) are fully described in Article 22 of Directive
75/319/EEC, and can be summarised as follows:
2.4.受权人（QP）的职责在75/319/EEC《指南》第22条款中有详细描述，
概括如下：
a) for medicinal products manufactured within the European Community, a Qualified Person must ensure that each batch has been produced and tested/checked in accordance with the directives and the marketing authorisation (1);
(1) According to Directive 75/319/EEC and the Ruling (Case 247/81) of the Court of Justice of the European Commununities, medicinal products which have been properly controlled in the EU by a Qualified Person
do not have to be recontrolled or rechecked in any other Member State of the Community.
(a)对于在欧共体内生产的药品，受权人必须确保每批药品的生产和检验符合
《指导》的条款和销售许可证(1)。
(b) for medicinal products manufactured outside the European Community, a Qualified Person must ensure that each imported batch has undergone, in the importing country, the testing specified in paragraph 1 (b) of Article 22;
(b)对于在欧共体之外生产的药品，受权人必须确保每批进口药品在进口国
均经过第22条款1(b) 中规定的检查。
(c) a Qualified Person must certify in a register or equivalent document, as operations are carried out and before any release, that each production batch satisfies the provisions of Article
22.
(c)受权人在产品放行前必须在记录或相应文件中证明每批产品符合第22条
款的规定。
The persons responsible for these duties must meet the qualification requirements laid down in Article 23 of the same Directive, they shall be permanently and continuously at the disposal of the holder of the Manufacturing Authorisation to carry out their responsibilities. Their responsibilities may be delegated, but only to other Qualified Person(s).
履行以上职责的人员必须符合《指南》第23条款的要求, 他们将始终如一、
持续地在生产企业中履行他们的职责。
2.5 .The head of the Production Department generally has the following responsibilities:
2.5.生产部门的负责人应负以下职责：
i. to ensure that products are produced and stored according to the appropriate documentation
in order to obtain the required quality;
i.确保产品按适当的文件进行生产和贮存，以达到质量要求。
ii. to approve the instructions relating to production operations and to ensure their strict
implementation;
ii.批准与生产操作相关的规程，并确保其严格地执行。
iii. to ensure that the production records are evaluated and signed by an authorized person before they are sent to the Quality Control Department;
iii.确保生产记录在送到质量控制部门前经受权人评估和签字。
iv. to check the maintenance of his department, premises and equipment;
iv.检查所属部门设施、设备的维护保养情况。
v. to ensure that the appropriate validations are done;
v.确保相关验证工作的进行。
vi. to ensure that the required initial and continuing training of his department personnel is carried out and adapted according to need.
vi.确保所属部门人员按照需要进行初级和继续的培训。
2.6 The head of the Quality Control Department generally has the following responsibilities:
2.6.质量控制部门负责人应负以下职责：
i. to approve or reject, as he sees fit, starting materials, packaging materials, and intermediate, bulk and finished products;
i.有权批准或拒绝原料、包装材料、中间产品、待包装产品和成品的使用或
发放。
ii. to evaluate batch records;
ii.评估批生产记录。
iii. to ensure that all necessary testing is carried out;
iii.确保所有必须检验项目的进行。
iv. to approve specifications, sampling instructions, test methods and other Quality Control procedures;
iv.批准质量标准、取样规程、检验方法和其它质量控制程序。
v. to approve and monitor any contract analysts;
v.批准和检查委托检验工作。
vi. to check the maintenance of his department, premises and equipment;
vi.检查所属部门设施、设备的维护保养情况。
vii. to ensure that the appropriate validations are done;
vii.确保相关验证工作的进行。
viii. to ensure that the required initial and continuing training of his department personnel is carried out and adapted according to need.
viii.确保所属部门人员按照需要进行初级和继续的培训。
Other duties of the Quality Control Department are summarised in Chapter 6.
质量控制部门的其它责任在第六章中概述。
2.7 The heads of Production and Quality Control generally have some shared, or jointly exercised, responsibilities relating to quality. These may include, subject to any national regulations:
2.7.生产部门和质量控制部门的负责人同行对质量负有分别或共同的责任。关于国家法规方面的内容包括：
◆The authorisation of written procedures and other documents, including
amendments;
◆书面程序和其它文件（包括修订）的批准；
◆the monitoring and control of the manufacturing environment;
◆生产环境监控；
◆plant hygiene;
◆工厂卫生；
◆process validation;
◆工艺验证；
◆training;
◆培训；
◆the approval and monitoring of suppliers of materials;
◆物料供应商的批准和检查；
◆the approval and monitoring of contract manufacturers;
◆合同生产厂的批准和检查；
◆the designation and monitoring of storage conditions for materials and products;
◆物料和产品贮存条件的确定和监控；
◆the retention of records;
◆记录的保存；
◆the monitoring of compliance with the requirements of Good Manufacturing
Practice;
◆检查对GMP的执行情况；
◆the inspection, investigation, and taking of samples, in order to monitor factors
which may affect product quality.
◆对影响产品质量的因素进行检查、调查和取样。
Training
培训
2.8 The manufacturer should provide training for all the personnel whose duties take them into production areas or into control laboratories (including the technical, maintenance and cleaning personnel), and for other personnel whose activities could affect the quality of the product.
2.8.生产厂应对进入生产区或质量控制实验室的人员（包括技术、维护和清
洁人员）以及那些从事的活动可能对产品质量产生影响的人员进行培训。
2.9 Besides the basic training on the theory and practice of Good Manufacturing Practice, newly recruited personnel should receive training appropriate to the duties assigned to them. Continuing training should also be given, and its practical effectiveness should be periodically assessed. Training programmes should be available, approved by either the head of Production or the head of Quality Control, as appropriate. Training records should be kept.
2.9.对于新员工，除GMP理论和操作的基础培训外，还应对他们进行与其岗位相关的职责培训，以及再培训，并定期评价培训的实际效果。培训应有计
划，并根据情况由生产部门或质量控制部门负责人批准。应保存培训记录。
2.10 Personnel working in areas where contamination is a hazard, e.g. clean areas or areas where highly active, toxic, infectious or sensitising materials are handled, should be given specific training.
2.10.对于在污染危险区（例如：洁净区或其它从事高活性、毒性、污染性
和致敏性物料的区域）工作的人员，应给予特殊的培训。
2.11 Visitors or untrained personnel should, preferably, not be taken into the production and quality control areas. If this is unavoidable, they should be given information in advance, particularly about personal hygiene and the prescribed protective clothing. They should be closely supervised.
2.11.参观人员和未经过培训的人员不得进入生产区和质量控制区域。如果这种情况不能避免时，应事先告诉他们在进入上述区域时，特别要注意个人
卫生并按规定穿戴防护服。对他们应严格监督。
2.12 The concept of Quality Assurance and all the measures capable of improving its understanding and implementation should be fully discussed during the training sessions.
2.12.培训期间，应对质量保证的概念和有助于增进对其理解、执行的所有措施进行充分讨论。
Personnel Hygiene
人员卫生
2.13 Detailed hygiene programmes should be established and adapted to the different needs within the factory. They should include procedures relating to the health, hygiene practices and clothing of personnel. These procedures should be understood and followed in a very strict way by every person whose duties take him into the production and control areas. Hygiene programmes should be promoted by management and widely discussed during training sessions.
2.1
3.应建立详细的卫生规程，并使之适应工厂内的不同需要，它应包括与
人员的健康、卫生行为、人员着装相关的程序。每一个进入生产和质量控制
区域的人员都应了解并严格执行这些程序。卫生规程应由管理人员改进，并
在培训时进行充分讨论。
2.14 All personnel should receive medical examination upon recruitment. It must be the manufacturer’s responsibility that there are instructions ens uring that health conditions that can be of relevance to the quality of products come to the manufacturer’s knowledge. After the first medical examination, examinations should be carried out when necessary for the work and personal health.
2.14.所有新招聘的人员都应接受身体检查。生产企业应确保有相关程序，以保证生产人员明白人员健康状况与产品质量密切相关。在第一次体检后，
应根据工作和个人健康状况的需要，再次进行体检。
2.15 Steps should be taken to ensure as far as is practicable that no person affected by an infectious disease or having open lesions on the exposed surface of the body is engaged in the manufacture of medicinal products.
2.15.应采取措施确保任何患有传染病及体表有外伤的人员不得从事药品生
产操作。
2.16 Every person entering the manufacturing areas should wear protective garments appropriate to the operations to be carried out.
2.16.所有进入生产区的人员应穿着与生产操作相适应的防护服。
2.17 Eating, drinking, chewing or smoking, or the storage of food, drink, smoking materials or personal medication in the production and storage areas should be prohibited. In general, any unhygienic practice within the manufacturing areas or in any other area where the product might be adversely affected, should be forbidden.
2.17.禁止在生产区和贮存区饮食、咀口香糖和吸烟，或贮存食品、饮料、香烟和个人药品。通常，在生产区或其它任何可能影响产品质量的区域禁止
任何不卫生的行为。
2.18 Direct contact should be avoided between the operator’s hands and the exposed product as well as with any part of the equipment that comes into contact with the products.
2.18.生产操作人员的手不得直接接触未包装的产品以及任何与产品接触的
设备部位。
2.19 Personnel should be instructed to use the hand-washing facilities.
2.19.应指导人员使用洗手装臵。
2.20 Any specific requirements for the manufacture of special groups of products, for example sterile preparations, are covered in the annexes.
2.20.特殊药品（如：无菌制剂）的生产要求见附录。
第三章厂房和设备
CHAPTER 3 PREMISES AND EQUIPMENT
Principle
原则
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.
厂房和设备的位臵、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，厂房和设备的布局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
通则
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.
3.1.厂房的位臵选择应在考虑保证生产的同时，可使对物料或产品产生污染
的危险减至低的环境。
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.
3.2.厂房的维护工作应细致，以确保在维修和维护保养操作不会危及产品质
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.
3.3.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
贮存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.
3.4.厂房的设计和配备应能最大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.
3.5.应采取措施防止未经准许的人员进入厂房。生产区、贮存区和质量控制
区不得成为不在这些地方工作的人员的通道。
Production Area
生产区
3.6 In order to minimise the risk of a serious medical hazard due to cross-contamination, dedicated and self contained facilities must be available for the production of particular medicinal products, such as highly sensitising materials (e.g. penicillins) or biological preparations (e.g. from live micro-organisms). The production of certain additional products, such as certain antibiotics, certain hormones, certain cytotoxics, certain highly active drugs and non-medicinal products should not be conducted in the same facilities. For those products, in exceptional cases, the principle of campaign working in the same facilities can be accepted provided that specific precautions are taken and the necessary validations are made. The manufacture of technical poisons, such as pesticides and herbicides, should not be allowed in premises used for the manufacture of medicinal products.
3.6.为了使由于交叉污染引起药品质量事故的危险减至最低限度，一些特殊药品[如：高致敏性物质（如：青霉素类）或生物制品（如：活微生物制品）的生产应采用专用设施。另外一些产品（如：某些抗生素、激素、细胞毒素、高活性药物和非医药用产品）的生产不应在同一设施中进行。在特殊情况下，这些产品的生产不得不使用同一设施时，可安排同一品种不同批次连续生产，但必须采取特殊的防范措施，并经过必要的验证。具有工业毒性的
产品（如：杀虫剂和除草剂）的生产不得与药品生产使用同一厂房。
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.
3.7.厂房应按实际生产制造的顺序及所要求的洁净级别进行合理布局。
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 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.
3.8.生产区和中间贮存区应足够大，设备和物料的摆放应有固定有规律的位