澳大利亚GMP中英对照

治疗用产品委员会

澳大利亚医用产品良好生产规范

2002年8月16日

Chapter 1

QUALITY MANAGEMENT 质量管理

PRINCIPLE 原理

The holder of a manufacturing authorization must manufacture medicinal products so as to ensure that they are fit for their intended use, comply with the requirements of the marketing authorization and do not place patients at risk due to inadequate safety, quality or efficacy.

制造权所有者必须生产医用产品以保证符合预期用途，与市场认可保持一致，并且不会由于不良的安全，质量及效果给患者带来风险。

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.

这些质量目标的达到不仅是高级管理人员的职责，而且需要公司很多不同的部门，各个层次的职员，以及供应商，销售商来参与并做出承诺。

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.

确保质量目标的达到必须有一个全面的策划及正确执行的质量保证体系，它由生产管理规范及质量控制结合而成。

It should be fully documented and its effectiveness monitored.

它应该充分的文件化并且监测它的效果。

All parts of the Quality Assurance systems should be adequately resourced with competent personnel, and suitable and sufficient premises, equipment and facilities.

质量保证体系的各个部分应该具备充分的资源，包括适当的人员，适宜的和充分的基础设施，设备和工具。

There are additional legal responsibilities for the holder of the manufacturing authorization and for the authorised person(s).

生产权所有人以及授权人具有附加的法律责任。

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.

质量保证，生产规范，质量控制的基本理论是相互联系的，这里的描述是要强调它们对医用产品的生产的控制的联系及重要性。

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.

1.2质量保证是一个具有广泛含义的概念，覆盖所有单一的或共同的影响产品质量的事宜It is the sum total of the organised 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 Code.

它是组织根据目标制定的措施的总和，以确保医用产品的质量符合预期使用的要求，质量保证因此结合了生产质量管理规范和其它不在本标准范围内的影响因素。

The system of Quality Assurance appropriate for the manufacture of medicinal products should ensure that:

适用于医用产品的质量保证体系应该确保：

i. medicinal products are designed and developed in a way that takes account of the requirements of Good Manufacturing Practice and Good Laboratory Practice;

医用产品的设计和开发应该考虑生产质量管理规范及实验室管理规范。

ii. production and control operations are clearly specified and Good Manufacturing Practice adopted;

生产和控制的操作规程清楚，符合生产管理规范要求。

iii. managerial responsibilities are clearly specified;

管理职责说明清楚。

iv. arrangements are made for the manufacture, supply and use of the correct starting and packaging materials;

生产，供应和正确的原料和包装材料的使用要制定措施。

v. all necessary controls on intermediate products, and any other inprocess controls and validations are carried out;

所有必需的对中间产品，过程的控制及验证被执行。

vi. the finished product is correctly processed and checked, according to the defined procedures;

通过规定的程序，正确的处理，检查最终产品。

vii. medicinal products are not sold or supplied before an authorised person has certified that each production batch has been produced and controlled in accordance with the requirements of the marketing authorization and any other regulations relevant to the production, control and release of medicinal products;

在授权人证实，每批产品都在规定的要求下生产出来，包括市场许可和其它医用产品的

相关生产、控制、销售法规等，医用产品不能销售或供应。

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;

存在符合要求的措施确保质量在保存期内保持不变，尽可能的直至医用产品储存，销售及随后搬运过程。

ix. there is a procedure for self-inspection and/or quality audit which regularly appraises the effectiveness and applicability of the quality assurance system.

有自我检查和/或质量审核的程序，周期性的评价质量保证体系的有效性与效率。

GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS (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 authorization or product specification.

生产管理规范是质量保证部的一部分，它将保证产品生产，控件制标准的一致性，适应于产品的使用目的和市场授权及产品说明的需要。

Good Manufacturing Practice is concerned with both production and quality control. The basic requirements of GMP are that:

生产管理规范与产品生产和质量控制有关，GMP的基本要求是：

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:

清楚的设计所有的生产处理操作，并且系统的回顾，来显示具备持续的生产符合要求和质量的医用产品的能力。

ii. critical steps of manufacturing processes and significant changes to the process are validated;

验证生产制造的关键处理步骤及显著的变更。

iii. all necessary facilities for GMP are provided including:

提供GMP需要的所有必要的资源：

a. appropriately qualified and trained personnel;适合的有资格以及经过培训人员；

b. adequate premises and space; 充足的设施及空间；

c. suitable equipment and services; 适当的设备并养护；

d. correct materials, containers and labels; 正确的物料，包装容器和标签；

e. approved procedures and instructions; 被批准的程序及指令；

f. suitable storage and transport; 适宜的储存及运输；

iv. instructions and procedures are written in an instructional form in clear and unambiguous language, specifically applicable to the facilities provided;

指令和程序的书写用富于教育性的形式，清清楚楚的语言，特别适用于提供的资源；v. operators are trained to carry out procedures correctly;

培训操作者正确的执行程序。

vi. records are made, manually an/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;

做记录，或以手写和/或机器记录，在生产过程中，记录可以证明每个步骤被程序，指令规定的要求真正实施，产品的数量，质量与期望保持一致，所有显著的偏差被详细记录并调查。

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;

包括销售记录在内的批记录有保持完整历史的能力，并可以追溯，保持形式易于理解和查找；

viii. the distribution (wholesaling) of the products minimises any risk to their quality;

产品销售（批发）降低质量风险到最小；

ix. a system is available to recall any batch of product, from sale or supply;

可以利用一个系统召回任一批销售的或供应的产品。

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 re-occurrence.

调查对市场上产品的抱怨，研究质量缺陷的原因，对有缺陷的产品采取适当的方法并且防止再发生。

QUALITY CONTROL 质量控制

1.4. Quality Control is that part of Good Manufacturing Practice which is concerned with sampling, specifications and testing, and with the organization, 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.

质量控制是生产管理规范的一部分，与取样，检查，检验有关，并且与组织机构,文件，放行程序有并，它将保证需要的有关检验被确实的执行，直至质量被判定符合要求，物料才能放行使用，产品才能销售或供应。

The basic requirements of Quality Control are that:质量控制的基本要求有：

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; 具备充分的工具，培训过的人员，被批准的程序实施取样，检查和检验原料，包装材料，中间体，未包装的及最终产品，并且具有适合于监测GMP要求的环境的条件。

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;

原料，包装材料，中间体，未包装的及最终产品的取样由为质量控制批准的人员及方法执行；

iii. test methods are validated;检验方法经过验证；

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;

记录手写和/或工具记录，记录证明所有需要的取样，检查和检验程序真正实施，任何偏差被充分的记录和调查；

v. the finished products contain active ingredients complying with the qualitative and quantitative composition of the marketing authorization, are of the purity required, and are enclosed within their proper container and correctly labelled;

最终产品包含的活性成分与市场承认的及纯度认可的定性及定量的指标一致，并且用适当的包装容器，正确的标识。

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;

记录下检查的结果，检验的结果，包括对原料，中间体，未完全包装和最终产品根据操作指南的正式评价。产品评价包括对相关产品文档的回顾和评估、偏离指定程序的评价。vii. no batch of product is released for sale or supply prior to certification by an authorised person that it is in accordance with the requirements of the marketing authorization;

实授权人根据市场认可的要求证实产品的符合性前，产品不能放行销售或供应。

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.

原料及产品保持充足留样，在将来需要时可以检验，并且产品应该以最后的包装形式保留，除非例外的大包装产品。

CHAPTER 2 PERSONNEL 第二章人事（管理）

原则

建立和维持一个令人满意的质量保证体系和药品的准确生产取决于人。因此，必须有足够的高素质员工来实施所有与生产相关的工作。员工应该清楚员工职责，并且要把这种责任记录下来。所有员工都应该了解与他们工作相关的优质生产实践的原则，并且得到初期和持续的培训，包括与他们需要有关的医学指导。

概要

2.1. 企业应该有足够的高素质的、有相关工作经验的员工。每个人身上的责任不应该过于集中以致于对（产品）质量造成威胁。

2.2. 企业必须有组织架构图。处于管理岗位上的人员应该有清晰的书面工作描述和实施他们职责所需的相应的权力。应当适度给（上述）那些人授予一定权力。对于负责优质生产实践的相关人员的职责不能模糊界定。

关键人员

2.3.关键人员包括生产负责人、质量控制负责人，如果这些人与产品的上市无关，则要由指定的权威人员来负责。通常关键岗位应该由全职员工来担任。生产和质量管理负责人应该彼此独立。在大企业中，应该指定一些列在2.5.，2.6.，2.7.上的职能。

2.4.……

2.5. 生产管理部门的负责人通常有以下职责：

i.确保产品按照相关文件生产和储存以保证产品质量；

ii.通过有关产品生产的指导说明，确保严格实施；

iii.在产品送去质检部之前，确保有指定人员核查、签署产品纪录；

iv.检查他的部门、前提和设备的保持情况；

v.确保完成相应的确认（事宜）；

vi.确保实施部门人员的初期和不断的培训，以及根据需要实施相应培训。

2.6. 质量控制部的负责人一般有如下职责：

i.根据个人见地，允许或者拒绝发放原料、包装材料、中间产品、散装产品或者

制成品；

ii.评估大批量订单；

iii.确保实施所有应该进行的试验；

iv.通过（产品）说明书、样品说明书、测试方法和其他的质量控制过程；

v.通过和监督任何合同分析者；

vi.监察他的部门、前提和设备保持情况；

vii.确保完成相应的确认（事宜）；

viii.确保实施部门人员的初期和不断的培训，以及根据需要实施相应培训。

质量控制部的其他职责详见第六章。

2.7. 生产和质量控制部的领导一般有一些共同的，或者共同经历的、与质量相关的责任。这些（责任）包括：

书写过程和其他文件的授权，包括修订；

监督和控制生产环境；

工厂卫生学；

批准程序；

培训；

通过和监督材料的供应；

通过和监督订约厂商；

指定和监督材料、产品的储存条件；

保留纪录；

监督与GMP要求的一致性；

监督、调查和取样，以有利于监督影响产品质量的因素。

培训

2.8. 企业应该为所有生产区人员或者进入控制范畴（包括技术、维护人员和清洁工），以及可能影响产品质量的其他人员提供培训。

2.9. 除了关于优质生产实践理论上和实际上的基础培训，新招募的员工应该接受与其职责相应的培训。应当给予他们持续的培训，而且对于他们的绩效应当进行定期考核。培训项目应当因地制宜，获得生产部或者质量控制部的负责人同意，（同时）要保存培训纪录。

2.10.危险区域，如清洁区、高污染区、高传染区或者处理敏感物料区的工作人员，应当获得特殊培训。

2.11.参观者或者未经培训者不能进入生产或者质量控制区。如果上述情况不可避免，应当提前告知这些人员一些信息，特别是关于人体卫生学和防护服（方面的信息），（而且要）应该密切监督上述事宜。

2.12.关于质量保证的内涵以及所有有利于理解和实施质量保证的措施都应该在培训会议上得到充分的论证。

人员卫生

2.1

3. 应当根据企业内部不同的需求建立和实施相应的具体的卫生学项目。这些项目应当包括与健康有关的程序，卫生实践和人员服装。生产和控制区的员工应该深刻理解和严格遵守这些程序。应当通过管理和培训会议上的广泛讨论来促进这些卫生学计划的实施。

2.14. 所有员工都应当在入司前体检。生产人员有责任保证与他们所熟知的产品质量相关的健康条件。在最初的体检之后，如有工作和人员健康需要，还可以进行体检。

2.15. 应当采取措施保证在生产药品时，无人染上传染病或者身体表面有任何伤口。2.16.每一个进入生产区的员工应当穿上与工作相关的防护服。

2.17.应当禁止在生产区和储存区吃、喝、咀嚼或者抽烟，或者储存食物、饮料、烟、或者个人药品。

2.18. 应当避免操作者的手直接接触药品，同样也应避免机器的任何部分直接接触（药品）产品。

2.19. 应当指导员工使用洗手液。

2.20.对于生产任何种类产品的具体要求，例如消毒准备，Annexes会涉及到。

CHAPTER 3 PREMISES AND EQUIPMENT 基础设施、设备

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.

基础设施设备必须座落，设计，建造并保持以适应将执行的操作。它们的布局和设计以减少发生差错的风险为目的，并且可以保持有效的清洁以避免交叉污染、灰尘和污垢产生、或任何对产品质量的不利影响。

PREMISES

General

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.

厂房应被置于这样一个区域：综合考虑了保护生产方的方法，产生原料或产品污染风险最小的方法。

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.

设施应精心维护，以确保维修和维护不会给产品质量带来危害。它们应被清洁，适当时通过有细节的书面程序被消毒。

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.

光照，温度，湿度，通风应该是适宜的，不会直接的或间接的对医疗产品产生不利影响，包括其生产、仓储过程，及所用设备的精确功能。

3.4. Premises should be designed and equipped so as to afford maximum protection against the entry of insects or other animals.

设施应设计并采用设备，以最大限度的防止昆虫或其它动物进入。

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.

采取步骤防止非授权人员进入，生产，储存和质量控制区域不可以用来作为非工作人员的通道。

Production Area 生产区域

3.6. In order to minimise the risk of a serious medical hazard due to crosscontamination, dedicated and self-contained facilities must be available for the production of particular medicinal products, such as highly sensitizing 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.

为降低由于交叉污染造成的严重医疗危害的风险，特殊医疗产品的生产必须使用专用的，独立的工具，如：高度光敏感物质（盘尼西林），生物制剂（如活的微生物）。如一些特殊产品的生产，如一些抗生素，某些激素，某些细胞毒素，某些高活性药物和非医用产品不能使用同一工具操作。就这些产品而言，有一些例外的案例，倘若采用了特殊的防范措施及进行了必须的验证，那么使用同一工具也是可以接受的。技术毒性的物质，如杀虫剂和除草剂，不允许在医用产品的设施内使用。

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.

设施应该适当的布局，使生产操作按照操作顺序和必备的清洁的合理顺序进行。

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 minimize 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.

充足的作业和生产过程仓储空间应可以使设备和物料有序的合理的放置，以降低发生不同的医用产品及它们的组分间混淆的风险，避免交叉污染，降低任何生产或质量控制的冗长或错误的应用的风险。

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.

在原料，包装材料，中间产品或未包装成品直接暴露在空气中地方，设施的内表面应该光滑，不爆裂，无开放的连接处，不脱落颗粒性物质，易于简便有效的清洁，如有必要，可能消毒。

3.10. Pipe work, 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.

管线，光源，通风口和其它设施维护应该被设计和安排以避免产生难于清洁的凹陷处，只要可能，出于维护的目的，它们应该可以从生产区域外达到。

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.

排水应有足够的尺寸，有收集的槽，如果可能的话避免使用开放的管道，但是如果需要用，它们应该浅一些便于清洁和消毒。

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.

生产区应有良好的通风，有空气控制设备，包括温度，必要时有湿度和过滤，适用于产品及执行的操作，和外部环境条件。

3.13. Weighing of starting materials usually should be carried out in a separate weighing room designed for that use.

原料称重通常应该在一个独立的设计好的操作间中执行。

3.1

4. 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.

如果产生灰尘（如在取样，称重，混合，处理操作，包装或干燥产品时），应该采取特别的措施避免交叉污染并便利的清洁。

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.

用于医用产品包装的设施应特别设计并安排以避免混乱和交叉污染。

3.16. Productions areas should be well lit, particularly where visual on-line controls are carried out.

生产区应有充足的光照，特别是有在线视觉控制的区域。

3.17. In-process controls may be carried out within the production area provided they do not carry any risk for the production.

如果成品不能有任何的风险，应该在生产区执行操作过程中的控制。

Storage Areas

仓储区域

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.

3.18. 储藏区域应该是具备充足的能力允许有秩序进行各种不同种类的材料和产品储藏：原料和包装材料，中间体，大量的散装板半成品和完成的产品，隔离的产品，发表，拒绝，退回或取消的。

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.

3.19. 储藏区域应该被设计的或适宜的确保良好的储藏条件。尤其，他们应该是干净的和干燥的并且在仓储区域内应维持一个可接受的温度限制要求。具备特别的储藏条件的地点是必需的(举例来说. 温度,湿度)这些应该被提供，检查而且检测。

3.20. Receiving and dispatch bays should protect materials and products from the

weather. Receptions areas should be designed and equipped to allow containers of incoming materials to be cleaned where necessary before storage.

3.20. 接受和急件分发应该保护材料和产品免于受天气的影响. 接收区域应该被设计而且装备允许收入材料被清理的容器哪里必需的在储藏之前.

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.

3.21. 在隔离状态在分开的区域中被储藏确定的地方，这些区域一定清楚地被作记号而且此区域的进入需经过认可的人员审批。无论任何一个系统区域更换实际的隔离工作应该提供相应的安全措施。

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.

3.22. 那里应该正常地是一个分开为开始材料抽取样品区域. 如果抽取样品在储藏区域中被运行,它应该以如此的一方式被引导当做避免污染或跨污染.

3.23. Segregated areas should be provided for the storage of rejected, recalled or

returned materials or products.

3.23. 隔离区域应该被提供为拒绝, 取消或被送回的材料或产品的储藏。

3.2

4. Highly active materials or products should be stored in safe and secure areas.

3.2

4. 具有高度不稳定（活跃）因素的材料或产品应该在冷藏库（保险箱）和安全的区域中储存。

3.25. Printed packaging materials are considered critical to the conformity of the

medicinal products and special attention should be paid to the safe and secure

storage of these materials.

3.25. 印刷包装材料是被认为的适合医学的产品和特别的注意应该被考虑到可靠的而且安全的对这些材料进行储藏.

Quality Control Areas 质量控制区域

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.

通常，质量控制实验室应与生产区域分开，这一点对生物，微生物，放射性同位素实验室特别重要。

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 crosscontamination. There should be adequate suitable storage space for samples and records.

质量检实验室应设计以适应执行的操作，有充足的空间来避免混乱和交叉污染。有充足的适当空间存放记录和样品。

3.28. Separate rooms may be necessary to protect sensitive instruments from vibration, electrical interference, humidity, etc.

使用独立的房间保护敏感设备，避免振动，电子干扰，湿度等。

3.29. Special requirements are needed in laboratories handling particular substances,such as biological or radioactive samples.

处理特殊物质的实验室需要特殊特殊条件，如生物或放射性样品。

Ancillary Areas 辅助区域

3.30. Rest and refreshment rooms should be separate from other areas.

休息和活动室应该与其它区域分开。

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，清洗和盥洗的设备易于使用并与使用者人数相适应，盥洗室不能与生产，仓储区直接相连。

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.

维护车间尽可能与生产区域分离，只要场所或工具在生产区域内，它们应保存在一定的空间内或上锁至使用时。

3.33. Animal houses should be well isolated from other areas, with separate entrance (animal access) and air handling facilities.

动物房应独立于其它区域，有单独的入口（动物使用）和空气处理设备。

EQUIPMENT

3.34 Manufacturing equipment should be designed , located and maintained to suit its intended purpose.

生产设备的设计、安装位置和维修维护都要与预期的目的相适应匹配。

3.35 Repair and maintenance operations should not present any hazard to the quality of the products.

任何维修维护工作不能危害产品的质量；

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.

生产设备应该设计成即能够方便清洗且能清洗干净；同时，要求设备有书面的详尽的清洗规程，设备必须储存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 .

设备的清洁洗涤要有选择性的使用，以防止不要使之成为一个新的污染源；

3.38 Equipment should be installed in such a way as to prevent any risk of error or of contamination.

设备的安装方法要防止任何错误的发生与污染产生的风险。

3.39 Production equipment should not present any hazard to the products . The parts of the 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.

生产设备不能显现出任何对产品有害的影响。浸入在产品中或产品与之接触的设备部件必须达到以下程度：1，不能与产品起反应；2，不能附带产品；3，不能吸附产品。这三点将对产品的质量构成危害或对产品具有潜在的危险。

3.40 Balances and measuring equipment of an appropriate range and precision should be available for production and control operations.

平衡测量设备必须具有适当的精度范围，使之在生产及控制操作中能够适用。

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 .

重力测量、记录、控制仪表设备应该通过适当的方法按固定的间隔校对和整定。到一定的检测次数后应该进行维修维护。

3.42 Fixed pipework should be clearly labeled to indicate the contents and , where applicable ,

the direction of flow.

固定安装的管道应该有清晰的标志标明它的介质，使用状态和流体流向。

3.43 Distilled ,deionized and , where appropriate ,other water pipes should be sanitized according to written procedures that detail the action limits for microbiological contamination and the measures to be taken .

蒸馏水、去离子水或其他适合的水管应该有书面的详尽的清洁程序；这将对微生物的污染与测量检验的执行进行了限制。

3.44 Defective equipment should be removed from production and quality control areas ,or at least be clearly labeled as defective.

有缺陷或带病的设备应该从生产区及质量控制区剔除，最起码也要用醒目的标签标明故障。

CHAPTER 4

第4章

DOCUMENTATION

文件

PRINCIPLE

原则

Good documentation constitutes an essential part of the quality assurance

system. Clearly written documentation prevents errors from spoken

communication and permits tracing of batch history. Specifications,

Manufacturing Formulae and instructions, procedures, and records must be free from errors and available in writing. The legibility of documents is of paramount importance.

好的文件组成是质量保证体系的必要部分。清楚地写文件可以避免错误的口头沟通和进行历史的追踪。规格、生产流程和指令、过程、生产记录必须是正确的手写形式。文件的可读性是最为重要。

GENERAL

通则

4.1. Specifications describe in detail the requirements with which the products or materials used or obtained during manufacture have to conform. They serve as a basis for quality evaluation.

Manufacturing Formulae, Processing and Packaging Instructions state all the

starting materials used and lay down all processing and packaging operations.

Procedures give directions for performing certain operations e.g. cleaning,

clothing, environmental control, sampling, testing, equipment operations.

Records provide a history of each batch of product, including its distribution,

and also of all other relevant circumstances pertinent for the quality of the final

product.

4.1产品、原料、在产品生产期间获得的中间体需要和说明书的详细描述一致。他们视为质量评估的一种基础。

生产流程、过程和包装说明规定了所有原料的使用和处理、包装操作。

程序对一些操作进行了指导，例如：清洁、着装、环境控制、取样、检验、设备操作。每一批产品的生产记录包括它的分发和产品最终质量相关的生产环境。

4.2. Documents should be designed, prepared, reviewed and distributed with care. They should comply with the relevant parts of the manufacturing and marketing authorization dossiers.

4.2 文件应当认真的编写、准备、讨论和分发。他们应当遵从制造业和行销的有关授权的文件。

4.3. Documents should be approved, signed and dated by appropriate and

authorised persons.

4.3 文件应该被适当的和授权的人批准、会签和签署日期。

4.4. Documents should have unambiguous contents; title, nature and purpose

should be clearly stated. They should be laid out in an orderly fashion and be

easy to check. Reproduced documents should be clear and legible. The

reproduction of working documents from master documents must not allow any error to be introduced through the reproduction process.

4.4 文件必须有明确的内容；题目、性质和目的应该清楚的描述。他们应该被放置在有秩序的格式中并且易被检查。升级文件必须清楚和清晰。引自主文件的工作文件在过程中不允许被错误的介绍。

4.5. Documents should be regularly reviewed and kept up-to-date. When a

document has been revised, systems should be operated to prevent inadvertent use of superseded documents.

4.5 文件应该有规律的被讨论和保持最新。当一个文件被修改，操作系统以避免替换文件所带来的疏忽。

4.6. Documents should not be hand-written; although, where documents require the entry of data, these entries may be made in clear, legible, indelible handwriting. Sufficient space should be provided for such entries.

4.6 文件不应该是手写的，但是，文件需要数据的输入，这些输入数据必须是清楚的、易读的和不能消除笔迹的。应该为这些数据输入提供充分的空间。

4.7. Any alteration made to the entry on a document should be signed and dated; the alteration should permit the reading of the original information. Where appropriate, the reason for the alteration should be recorded.

4.7 任何文件内容的变更都必须要经过签名和签署日期。变更应该允许读到最初的信息，记录变更原因。

4.8. The records should be made or completed at the time each action is taken and in such a way that all significant activities concerning the manufacture of medicinal products are traceable. They should be retained for at least one year after the expiry date of the finished product.

4.8 当每一个生产操作实施时，生产记录应该记录。同样，制造药品的重要活动应该是可以追述的。生产记录应该至少保持到产品有效期后1年。

4.9. Data may be recorded by electronic data processing systems, photographic or other reliable means, but detailed procedures relating to the system in use should be available and the accuracy of the records should be checked. If documentation is handled by electronic data processing methods, only authorised persons should be able to enter or modify data in the computer and there should be a record of changes and deletions; access should be restricted by passwords or other means and the result of entry of critical data should be independently checked. Batch records electronically stored should be protected by back-up transfer on magnetic tape, microfilm, paper or other means. It is particularly important that the data are readily available throughout the period of retention,.

4.9 数据可能被电子数据处理系统记录，照相的或其它可靠的方法，但是使用的体系有关的详细的程序必须是有用的，而且记录的精确性应该被检查。如果文件用电子数据处理方法记载，只有授权人有能力进入计算机检测数据，并且这些变更和删减必须记录；入门必须用密码或其它方法进行严格限制，输入数据的结果必须独立的检查。一批电子生产记录可以用磁带、胶片、纸张或其它方法进行备份储存。一些重要的数据应该在保持过程中容易获取。

DOCUMENTS REQUIRED

必须的文件

Specifications

说明书

4.10 There should be appropriately authorised and dated specifications for starting and packaging materials, and finished products; where appropriate, they should be also available for intermediate or bulk products.

4.10 对起始材料、包装材料、最终成品和中间体、待包装产品都应该有授权的和签署日期的规范。

Specifications for starting and packaging materials

起始原料和包装原料的说明

4.11. Specifications for starting and primary or printed packaging materials should include, if applicable:

4.11 起始原料和重要的包装材料的说明适用以下内容：

a) a description of the materials, including:

原料描述包括以下内容：

! the designated name and the internal code reference;

指定的名字和内在的相关代码；

! the reference, if any, to a pharmacopoeial monograph;

参考的或任何有关的药学专论；

! the approved suppliers and, if possible, the original producer of the products;

认可的供应商，如果可能的化，产品的生产者；

! a specimen of printed materials;

印刷材料的样本；

b)directions for sampling and testing or reference to procedures;

关于取样和检测的或者相关的程序；

c)qualitative and quantitative requirements with acceptance limits;

性质和数量上可以接受的界限；

d)storage conditions and precautions;

储存环境和预防措施；

e) the maximum period of storage before re-examination.

在复检之前的最长储存期。

Specifications for intermediate and bulk products

中间体和待包装品的说明

4.12. Specifications for intermediate and bulk products should be available if these are purchased or dispatched, or if data obtained from intermediate products are used for the evaluation of the finished product. The specifications should be similar to specifications for starting materials or for finished products, as appropriate.

4.12用于最终产品的中间体数据，或购买的、分配的中间体和待包装品的说明应该是有用的。这些说明应该与起始原料或最终产品的说明是类似的。

Specifications for finished products

最终产品的说明

4.13. Specifications for finished products should include:

4.13 最终产品的说明应该包括以下内容：

a)the designated name of the product and the code reference where applicable;

适用的产品指定的名字和相关的代码；

b)the formula or a reference to;

公式或者相关的参考；

c) a description of the pharmaceutical form and package details;

描述药学成分和包装的详细资料；

d)directions for sampling and testing or a reference to procedures;

关于取样和检测的或者相关的程序；

e)the qualitative and quantitative requirements, with the acceptance limits;

性质和数量上可以接受的界限；

f)the storage conditions and any special handling precautions, where applicable;

适用的储存条件和任何特殊的处理预防措施；

g)the shelf-life.

保存期。

MANUFACTURING FORMULA AND PROCESSING INSTRUCTIONS

制造流程和处理指令

Formally authorised Manufacturing Formula and Processing Instructions should exist for each product and batch size to be manufactured. They are often combined in one document.

在每一个产品和每一批制造尺寸中都存在正式授权的制造流程和处理指令。它们经常在一个文件中联合。

4.14. The Manufacturing Formula should include:

4.14 制造流程应该包括以下内容：

a)the name of the product, with a product reference code relating to its specification;

产品的名称，与产品规格相关的产品代码；

b) a description of the pharmaceutical form, strength of the product and batch size;

药学成分、产品浓度和批大小的描述；

c) a list of all starting materials to be used, with the amount of each, described using the

designated name and a reference which is unique to that material; mention should be made of any substance that may disappear in the course of processing;

所有起始原料的清单，包括每一个的数量，使用的指定名字的描述和原料独特的参考文献；提及在处理过程中可能消失的任何物质。

d) a statement of the expected final yield with the acceptable limits, and of relevant

intermediate yields, where applicable.

可接受的预期最终利益和应用的相关中间利益的陈诉

4.1

5. The Processing Instructions should include:

4.15 处理过程的说明应该包括以下内容：

a) a statement of the processing location and the principal equipment to be used;

对处理场所和主要使用设备的说明；

b)the methods, or reference to the methods, to be used for preparing the critical equipment

(e.g. cleaning, assembling, calibrating, sterilizing);

用在准备评价设备（例如：洁净度、配置、校准、）的方法或参考的方法，

c)detailed stepwise processing instructions (e.g. checks on materials,

pretreatments, sequence for adding materials, mixing times, temperatures);

逐条逐步的处理说明（例如：原料的检查、预处理、加入原料的顺序、混合的次数、温度）

d)the instructions for any in-process controls with their limits;

任何不在过程控制界限内的说明；

e) where necessary, the requirements for bulk storage of the products;including the container, labelling and special storage conditions where applicable;

任何必须的产品待包装区域的需求，包括适用的容器、标签和特殊的储存环境；

e)any special precautions to be observed.

任何特别的预防措施都要遵守。

PACKAGING INSTRUCTIONS

包装说明

4.16. There should be formally authorised Packaging Instructions for each product for pack size and type. These should normally include, or have a reference to, the following:

4.16 每一个产品的包装尺寸和类型都应当被正式的授权说明，这些通常包括或者相关的下列内容。

a)name of the product;

产品的名称；

b)description of its pharmaceutical form, and strength where applicable;

应用的药学组成、浓度的描述；

c) the pack size expressed in terms of the number, weight or volume of the

product in the final container;

描述包装大小、重量或产品在容器中的提及；

d) a complete list of all the packaging materials required for a standard

batch size, including quantities, sizes and types, with the code or reference number relating to the specifications of each packaging material;

一个完整的包装材料的清单需要标准的一批尺寸，包括数量、大小和类型、每一个包装原料的代码和相关的数字。