澳大利亚GMP中英对照.doc

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 1QUALITY 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 companys 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 ofdeviations 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。. 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2.13. 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。PREMISESGeneral3.1. 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。3.14. 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 thevarious 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 withinacceptable temperature