【共享】现行欧盟GMP第4卷及其附录中英对照

2010年毕业到现在已经一年了，做了一年的中药注册。由于公司小，钱又少得可怜，没啥发展前途，最近想转行了，希望到大点的公司做药品RA或跟英语有点关系的职位。最近在网上到了一家公司招药品翻译员，想去试试，但心里实在是没底，所以打算先充电一下再投简历。以下是我今天尝试翻译的欧盟现行GMP第四卷第一部分的第一章，以后每天我会更新我的最新翻译。原文在Public Health 可以找到。 网址：http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm，网站上是PDF版的，我自己已转化为WORD 版，有人需要可以留邮箱。如果有人已在这个行业发展的，我希望能得到你的建议。希望有大侠点播一下，小弟感激不尽。好了，废话少说，以下是 chapter one
Volume 4EU Guidelines toGood Manufacturing PracticeMedicinal Products for Human and Veterinary Use Part IChapter 1 Quality Management第一章质量管理

Principle

原则



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, Quality Control and Quality Risk Management. 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).

生产许可证拥有者需生产符合药用目的和注册要求的药品，使患者不承担安全、质量、疗效等风险。达到此质量目标是高层管理的责任，但也需要公司内各部门各阶层的员工以及公司供应商和销售商共同参与和承担。为切实达到这一质量目标，必须有一个综合设计，并正确运行的质量保证体系，包括GMP、质量控制和风险管理。质量保证体系必须文件化，并（实时）监督其有效性。质量保证体系的所有组成部分必须配备充足的技能人员、合适的设施、仪器和设备。另有其他法规规定了企业负责人和质量管理负责人的职责。

The basic concepts of Quality Assurance, Good Manufacturing Practice, Quality Control and Quality Risk Management 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、GMP、质量控制和风险管理具有内在联系，为了强调它们之间的关系以及它们在生产和控制过程中的重要性，在此，对它们的基本概念进行阐述。

Quality Assurance

质量保证



1.1 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 organised arrangements made with the objective 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.

质量保证是一个广义的概念，覆盖了所有单独和综合影响产品质量的因素。它是保证生产的药品符合预定用途的所有经确定的措施的总称

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

符合药品生产的质量保证体系应满足以下要求：

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

药物的设计和研发需符合GMP的要求

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

生产和控制有明确的操作说明，并符合GMP的要求

(iii) managerial responsibilities are clearly specified;

管理人员的责任需明确

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

制定措施确保在生产，供应和使用过程中使用的是正确的原材料和包装材料

(v) all necessary controls on intermediate products, and any other in-process controls and validations are carried out;

对中间品进行必要检控，生产过程需进行控制和验证。

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

成品需按照确定的规程进行生产的检验。

(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;

在质量放行人确定整批产品的生产和检测结果符合注册标准和其他生产、控制和放行规定之前，药品不能够出售和供应。

(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;

有有效的措施尽可能控制产品在有其效期内的储藏、发放和后续处理过程中，保持质量稳定。

(ix) there is a procedure for Self-Inspection and/or quality audit, which regularly appraises the effectiveness and applicability of the Quality Assurance system.

有自查或监查规程，定时评估质量保证体系的有效性和适应性。

Good Manufacturing Practice for Medicinal Products (GMP)

药品GMP



1.2 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.

GMP是质量保证体系的一部分，确保企业能够持续稳定地控制和生产符合预定要求、质量标准的和注册标准的药品

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

GMP包含生产和质量控制，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;

生产工艺操作规程需明确规定，并进行系统性历史回顾，保证有能力持续稳定地生产出达到质量要求并符合质量标准的药物。

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

生产工艺的关键步骤或重大变更需进行验证；

(iii) all necessary facilities for GMP are provided including:

GMP要求的必须设备包括：

? appropriately qualified and trained personnel;

适量的资质人员

? adequate premises and space;

充裕的厂房和空间

? suitable equipment and services;

合适的设备和服务

? correct materials, containers and labels;

正确的原材料，包装材料和标签

? approved procedures and instructions;

经批准的规程和操作说明

? suitable storage and transport;

适当的储运条件

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

操作规程用指示性格式书写，语言清晰明了，特别是有关的仪器和设备；

(v) operators are trained to carry out procedures correctly;

操作员工都经过培训以便可以正确操作；

(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;

生产过程需由人工或仪器制作生产记录，以证明操作规程所要求所有步骤都已完成，产品的质量和数量达到预期标准。任何重大偏差需进行完整记录并调查原因。

(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;

生产和发放记录清晰易查，并确保能够追溯整批产品的生产全过程；

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

产品的发放需（采取措施）降低影响产品质量的任何风险

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

具有合适的产品召回系统，可召回任一批次的已销售或供应的产品

(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 reoccurrence.

关于已上市销售产品的投诉须进行检查，并调查质量缺陷的原因，采取适当的措施防止有缺陷的产品再次发生

Quality Control

1.3 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.

质量控制是GMP的一部分，包括抽样、质量标准、检测、组织架构、文件系统以及发放规程。发放规程应确保必要的和相关的检验如实进行，并保证物品在检验合格前不得发放使用和供应。

The basic requirements of Quality Control are that:

质量控制基本要求如下：

(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;

有充足的设备和技术人员；经批准的适合原料、包装材料、半成品、待检产品和成品的抽样、检验和测试规程；适时监测环境条件是否符合GMP要求。

(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、半成品、待检产品和成品的抽样需由专员执行，抽样方法需由质量控制部门批准

(iii) test methods are validated;

测验方法经过验证

(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;

（数据）需由人工或仪器进行记录，证明所要求的抽样、检验和测试如实进行。偏差需完整记录并调查（原因）

(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;

药品含有药物活性成分的，其活性成分的性质和数量需与注册批准的一致，纯净度需符合要求。药物需用合适的材料进行包装，并有正确的标示。

(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;

原料、包装材料、半成品、待检产品、成品通常根据标准进行检验和测定，结果需进行记录保存。产品评估包括回顾和评介相关的生产文件记录以及通过确定的规程对偏差进行评估。

(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 relevant authorisations;

在质量放行人批准产品已达到相关批准的要求之前，任何批次的产品都不能放行销售和供应

(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.

保留有足够的与原料、产品相关的样品，以满足以后产品的必要性检查。成品一般以最后包装留样，但特别巨大的包装除外。

Product Quality Review

产品质量回顾



1.4 Regular periodic or rolling quality reviews of all licensed medicinal products, including export only products, should be conducted with the objective of verifying the consistency of the existing process, the appropriateness of current specifications for both starting materials and finished product to highlight any trends and to identify product and process improvements. Such reviews should normally be conducted and documented annually, taking into account previous reviews, and should include at least:

经注册的药品（包括只用于出口的药品）需进行周期性的质量回顾，验证现在工艺的持续性以及现在原料和成品规范的适用性，以发现缺陷和确定产品和工艺的改进方法。质量回顾需综合考虑历史回顾情况，每年进行并形成文件记录，

(i) A review of starting materials including packaging materials used in the product, especially those from new sources.

原料的回顾，包括在生产中使用的包材。特别是来新来源的材料。

(ii) A review of critical in-process controls and finished product results.

过程控制关键点以及成品结果的回顾

(iii) A review of all batches that failed to meet established specification(s) and their investigation.

不符合既定标准批次以及原因的回顾

(iv) A review of all significant deviations or non-conformances, their related investigations, and the effectiveness of resultant corrective and preventative actions taken.

重大偏差或不达标产品、相关原因调查、采用相关整改和防护措施的效果的回顾

(v) A review of all changes carried out to the processes or analytical methods.

工艺或分析方法变更的回顾

(vi) A review of Marketing Authorisation variations submitted/granted/refused, including those for third country (export only) dossiers.

已提交的、成功的、失败的注册变更申请档案（包括向第三国申请提交的）的回顾。

(vii) A review of the results of the stability monitoring programme and any adverse trends.

稳定性考察结果和不良趋势回顾

(viii) A review of all quality-related returns, complaints and recalls and the investigations performed at the time.

质量原因退货、投诉、产品召回以及采取的调查的回顾

(ix) A review of adequacy of any other previous product process or equipment corrective actions.

以前改进的工艺和设备的完善程度的回顾

(x) For new marketing authorisations and variations to marketing authorisations, a review of post-marketing commitments.

新药注册或更正注册事项的药品上市后的情况回顾，

(xi) The qualification status of relevant equipment and utilities, e.g. HVAC, water, compressed gases, etc.

相关仪器设备的确认状态回顾，如空调净化系统、水、压缩空气等。

(xii) A review of any contractual arrangements as defined in Chapter 7 to ensure that they are up to date.

对第七章规定的协议进行回顾，以确保它们实时更新。

The manufacturer and marketing authorisation holder should evaluate the results of this review, where different, and an assessment made of whether corrective and preventative action or any revalidation should be undertaken. Reasons for such corrective actions should be documented. Agreed corrective and preventative actions should be completed in a timely and effective manner. There should be management procedures for the ongoing management and review of these actions and the effectiveness of these procedures verified during self- inspection. Quality reviews may be grouped by product type, e.g. solid dosage forms, liquid dosage forms, sterile products, etc. where scientifically justified.

生产商和生产许可持有人对回顾的结果进行评估，如果与现在有差异，需**整改和防护措施，或进行再验证。整改或防护理由需有文件记录，同意整改和防护的措施需及时有效。应有管理规程管理这些措施，并对这些措施进行回顾，在自检过程中确定其有效性。当有合理的科学方法时，质量回顾可以按产品的分类进行。如：固体制剂、液体制剂、无菌制剂等。

Where the marketing authorisation holder is not the manufacturer, there should be a technical agreement in place between the various parties that defines their respective responsibilities in producing the quality review. The Qualified Person responsible for final batch certification together with the marketing authorisation holder should ensure that the quality review is performed in a timely manner and is accurate.

当生产许可证持有人与生产商不同时，双方必须签订技术性协议，明确双方在进行质量回顾时需承担的责任。负责产品最终放行的质量放行人与生产许可证持有者共同保证质量回顾及时正确地进行。

Quality Risk Management

质量风险管理



1.5 Quality risk management is a systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product. It can be applied both proactively and retrospectively.

质量风险管理是一种对药品生产过程中的质量风险进行评估、控制、沟通和检验的系统过程，它可以采用前瞻性也可以采用回顾性的模式。

1.6 The quality risk management system should ensure that:

质量风险管理体系必须确保：

- the evaluation of the risk to quality is based on scientific knowledge, experience with the process and ultimately links to the protection of the patient

质量风险需以科学的理论知识，生产的经验为基础，并最终以患者的安全为考虑因素。

- the level of effort, formality and documentation of the quality risk management process is commensurate with the level of risk

质量风险处理所需的努力、形式和证明需和风险级别相适应。

Examples of the processes and applications of quality risk management can be found inter alia in Annex 20.

风险管理的应用和操作例子参见附录20