PICS GMP中英文对照

1、行政院卫生署药物食品检验局guide to good manufacturing practice for medicinal products国际药品审计合作组织(pic/s)药品生产质量管理规范指引主办单位：卫生署药政处、药物食品检验局协办单位：经济部工业局承办单位：社团法人台湾药物质量协会日期：2003年192chapter 1quality management第一章质量管理principlethe holder of a manufacturing authorization must manufacture medicinal products so as to ensure th

2、at 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. the attainment of this quality objective is the responsibility of senior management and requires the participation and

3、commitment by staff in many different departments and at all levels within the company, by the companys suppliers and by the distributors.原则 制造许可证的持有者，应遵循上市许可的要求去制造药品，以确保药品适合其所预期的用途，并且，不会由于不适当的安全性、质量或有效性而使病人受到危害。这种质量目标的达成，是高层管理者的责任，而且需要由公司之内的许多不同部门以及所有阶层之人员的参与及承诺，也需要公司的供货商以及经销商的参与及承诺。to achieve the

4、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 systems shou

5、ld 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 authorization and for the authorised person(s).要可靠地达成这个质量目标，应有经过全面设计和正确实施的质量保证系统, 该系统涵盖药品生产质量管理规范与质量控制。

6、它应完全文件化，并且要监督它的效果。质量保证系统的所有部门，应适当配置权责人员，也要有合适而且足够的厂房、设备与设施。对于制造许可证的持有者以及被授权的人员，须另负其它法律责任。1.1. the basic concepts of quality assurance, good manufacturing practice and quality control are inter-related. they are described here in order to emphasis their relationships and their fundamental importance

7、to the production and control of medicinal products.1.1. 质量保证、药品生产质量管理规范和质量控制的基本观念，是相互关联的，故在本章中叙述，以强调其彼此间的关系及其对药品之生产和控制的重要性。quality assurance1.2. 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

8、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 guide. the system of quality assurance ap

9、propriate for the manufacture of medicinal products should ensure that:质量保证1.2. 质量保证是一个广泛的概念，它涵盖了个别地或集体地影响到一个产品之质量的所有事项。质量保证是以确保药品具有其所预期使用所需要的质量为其目标所做之有组织的安排总和。因此，质量保证是把药品生产质量管理规范再加上本指引范围以外的其它因素结合在一起。这种适合于药品制造的质量保证系统应当确保下列事项：i. medicinal products are designed and developed in a way that takes accoun

10、t of the requirements of good manufacturing practice and good laboratory practice;i. 药品是以考虑药品生产质量管理规范及优良实验室规范()之要求的方式予以设计并开发的；ii. production and control operations are clearly specified and good manufacturing practice adopted;ii. 生产和控制作业应予清楚规定，并采用药品生产质量管理规范；iii. managerial responsibilities are clear

11、ly specified;iii. 管理责任应予清楚规定；iv. arrangements are made for the manufacture, supply and use of the correct starting and packaging materials; iv. 对于正确之原料与包装材料的制造、供应与使用做出安排；v. all necessary controls on intermediate products, and any other in-process controls and validations are carried out;v. 半成品/中间产品的

12、所有必要控制，以及任何其它制程中的控制与验证均已执行；vi. the finished product is correctly processed and checked, according to the defined procedures;vi. 最终产品是依所规定的程序予以正确地操作与核对；vii. medicinal products are not sold or supplied before an authorised person has certified that each production batch has been produced and controlle

13、d in accordance with the requirements of the marketing authorization and any other regulations relevant to the production, control and release of medicinal products;vii. 药品在被授权人员证实其每一生产批次已经依上市许可及有关药品之生产、控制及放行的任何相关法规之要求予以生产与控制之前，是不会被销售与供应的。viii. satisfactory arrangements exist to ensure, as far as po

14、ssible, that the medicinal products are stored, distributed and subsequently handled so that quality is maintained throughout their shelf life; viii. 具有令人满意的安排，以尽可能确保药品的储存、运销以及后续的处理，使其能在架储期间维持其质量；ix. there is a procedure for self-inspection and/or quality audit which regularly appraises the effectiv

15、eness and applicability of the quality assurance system.ix. 有一套自查及/或质量审计的程序，藉以定期评估质量保证系统的有效性及适用性。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 contr

16、olled to the quality standards appropriate to their intended use and as required by the marketing authorization or product specification. good manufacturing practice is concerned with both production and quality control. the basic requirements of gmp are that:1.3. 药品生产质量管理规范是质量保证的一部份，它确保药品是一致性地生产及控制

17、以达到适合其所预期的用途及如上市许可或产品规格所要求的质量标准。药品生产质量管理规范是与生产及质量控制两者有关。基本的gmp要求为：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 specifica

18、tions:i. 所有制造过程均已加以清楚规定，按照经验作有系统的复审，而且，要能显出一致性地制造所要求的质量以及符合其规格的药品。ii. critical steps of manufacturing processes and significant changes to the process are validated;ii. 制造过程的关键步骤以及对于工艺的重大变更，均是经过验证的；iii. all necessary facilities for gmp are provided including:iii. 提供药品生产质量管理规范的所有必要条件包括：a. appropriate

19、ly qualified and trained personnel;a. 经适当资格检定与培训的人员；b. adequate premises and space;b. 足够的厂房设施与作业空间；c. suitable equipment and services;c. 适当的设备及支持服务；d. correct materials, containers and labels;d. 正确的原物料、容器和卷标；e. approved procedures and instructions;e. 经核准的程序和指令；f. suitable storage and transport;f. 适当

20、的储存及运送；iv. instructions and procedures are written in an instructional form in clear and unambiguous language, specifically applicable to the facilities provided;iv. 指令及程序是一种指导性的型式以清楚且明确的语言所书写，尤其适用于所提供的设施； v. operators are trained to carry out procedures correctly;v. 操作者受过培训以正确地执行程序；vi. records are

21、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 investiga

22、ted;vi 在制造期间，以手工及/或记录仪制作记录，藉以确认由所规定的程序与指令所要求的所有步骤业已实际采行，而且，产品的数量与质量是如其所预期的。任何重大的偏差均完整加以记录并调查。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;vii. 可以追踪一个批次其完整历程的制造记录，包含其运销在内，是以一种可理解且易取得的

23、形式保存；viii. the distribution (wholesaling) of the products minimizes any risk to their quality; viii. 产品的运销(批发)，要使其对产品质量的任何危害减到最小。ix. a system is available to recall any batch of product, from sale or supply;ix. 具一回收系统，可以从销售或供应点上回收任何批次的产品。x. complaints about marketed products are examined, the causes

24、 of quality defects investigated and appropriate measures taken in respect of the defective products and to prevent re-occurrence.x. 检查关于上市产品的投诉，调查质量瑕疵的原因，并且对于有瑕疵的产品能采取适当的措施并防止其再度发生。quality control质量控制1.4. quality control is that part of good manufacturing practice which is concerned with sampling,

25、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 sat

26、isfactory. the basic requirements of quality control are that:1.4 质量控制是药品生产质量管理规范的一部份，它与取样、规格及测试有关，也与组织、文件与放行程序有关，用以确保已确实执行必要及相关的试验，而且，也确保原物料与产品的质量已经判定满意，始放行使用、销售或供应。质量控制的基本要求是：i. adequate facilities, trained personnel and approved procedures are available for sampling, inspecting and testing starti

27、ng materials, packaging materials, intermediate, bulk, and finished products, and where appropriate for monitoring environmental conditions for gmp purposes;i. 具有足够的设施、受过培训的人员以及核准过的程序，以供取样、查核和测试原料、包装材料、半成品/中间产品、待分/包装产品与最终产品，并在合适时，供用于监督为药品生产质量管理规范目的的环境条件。ii. samples of starting materials, packaging m

28、aterials, intermediate products, bulk products and finished products are taken by personnel and by methods approved by quality control;ii. 原料、包装材料、半成品/中间产品、待分/包装产品和最终产品的样品，是由经由质量控制部门所核准的人员以及所核准的方法所抽取；iii. test methods are validated;iii. 检验方法是经过验证的；iv. records are made, manually and/or by recording i

29、nstruments which demonstrate that all the required sampling, inspecting and testing procedures were actually carried out. any deviations are fully recorded and investigated;iv. 以手工及/或记录仪制作记录，藉以确认已确实执行所有要求的取样、查核以及测试程序。任何的偏差均完整加以记录并调查。v. the finished products contain active ingredients complying with

30、the qualitative and quantitative composition of the marketing authorization, are of the purity required, and are enclosed within their proper container and correctly labelled;v. 含有有效成分的最终产品符合上市许可的定性与定量组成，具有所要求的纯度，且密封在适当容器内，并正确地标示。vi. records are made of the results of inspection and that testing of

31、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. 查核与试验结果均须做成记录，前项试验系指对原物料、半成品/中间产品、待分/包装产品与最终产品的测试是正规

32、地对照其规格进行评估。产品评估包含有相关生产文件的复审与评估以及与规定程序之偏差的评估。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;vii. 每批产品应经由被授权人员确认符合上市许可的要求，始可放行以供销售或供应。viii. sufficient reference samples

33、 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. 保留足够的原料与产品的参考样品，以容许未来必要时产品的检查，而且，这种产品是保留在它的最终包装中，除非该包装是异常地庞大。quality review 质量评审regular per

34、iodic 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 highligh

35、t 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:(i) a review of starting materials and packaging materials used for the product,especially those from ne

36、w sources. (ii) a review of critical in-process controls and finished product results.对关键的过程控制和成品结果的评审(iii) a review of all batches that failed to meet established specification(s) and their investigation.对不符合既定规格所有批次及其调查情况的评审；(iv) a review of all significant deviations or non-conformances, their re

37、latedinvestigations, and the effectiveness of resultant corrective and preventativeactions taken.对所有的重大偏差或不符合情况及其调查情况的评审，包括由此产生产纠正和预防措施效果的评审；(v) a review of all changes carried out to the processes or analytical methods.对工艺或分析方法方面所发生的所有变更的评审；(vi) a review of marketing authorisation variations submit

38、ted/granted/refused,including those for third country (export only) dossiers.对所递交的/批准的/拒绝的上市许可的变化的评审，包括那些向第三国（仅供出口）递交的文档；(vii) a review of the results of the stability monitoring programme and any adverse trends.对稳定性监控结果及任何不良趋势的评审；(viii) a review of all quality-related returns, complaints and recall

39、s and theinvestigations performed at the time.对所有与质量有关的退货、投诉和召回及所进行的调查的评审；(ix) a review of adequacy of any other previous product process or equipmentcorrective actions.对所有其他以前产品或设备的纠正措施适宜性的评审(x) for new marketing authorisations and variations to marketing authorisations, a review of post-marketing

40、commitments.对新上市许可和对上市许可的变更，评审上市后的承诺的执行情况；(xi) the qualification status of relevant equipment and utilities, e.g., water,compressed gases, etc.对相关的设备设施确认状况的评审，如，空调系统（hvac）、水系统、压缩空气等；(xii) a review of technical agreements to ensure that they are up to date.对技术协议的评审，以确保他们得到及时更新。为确认现有工艺的一贯性，确认现有原辅料、产成品

41、质量规格的适宜性，发现质量趋势及识别出产品和工艺方面的改进需求，应定期或滚动性的对所有经批准生产的产品，包括仅供出口的产品，进行评审。这种评审通常每年进行一次并及时记录，评审应考虑以前的评审结果，并至少包括：对用于产品生产的原辅料和包装材料的评审，特别是新来源的物料；chapter 2第二章personnel人事principle原则the establishment and maintenance of a satisfactory system of quality assurance and the correct manufacture of medicinal products re

42、lies 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 goo

43、d manufacturing practice that affect them and receive initial and continuing training, including hygiene instructions, relevant to their needs.一个令人满意的质量保证系统的建立和维持，以及，药品的正确制造和控制，均是仰赖于人。基于此理，应有足够的合格的人员，以执行所有的工作，这是药厂的责任。个别的责任应被每一位工作人员所清楚了解并作成记录，所有的人员均应知悉会影响到他（她）们的药品生产质量管理规范的原则，并接受初始及持续的培训，包括与员工需求相关的卫生指

44、导。general一般规定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. 药厂应配置足够之合格及具实际经验的人员，所赋予每个人的责任不应过于广泛，以免导致对质量呈现

45、出危害。2.2. the manufacturer must have an organization 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

46、 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. 药厂应有组织图。各职务负责人，应有书面说明其特定的工作职责，且应获得适当的授权以执行其责任。各职务负责人的职责可以委派给够资格的指定代理人。对于执行优良制造实务的工作人员，其责任分工上应该没有遗漏或者没有未经说明的部份重叠。key personnel关键人员2.3.

47、key personnel includes the head of production, the head of quality control, and if at least one of these persons is not responsible for the release of products the authorised person(s) designated for the purpose. normally key posts should be occupied by full-time personnel. the heads of production a

48、nd 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. 关键人员包括有生产主管、质量控制主管，以及如果这两个人中至少有一位不负责产品放行时，还要有一位为此目的所指定的被授权人员。通常这些重要的职位应由专职人员担任，制造和质量控制部门的主管应相互独立。大型药厂对于2.5、2.6、及2.7上所列举的一些职务可能应有委派人员

49、。2.5. the head of the production department generally has the following responsibilities:2.5. 生产部门的主管一般具有下列责任:i. to ensure that products are produced and stored according to the appropriate documentation in order to obtain the required quality;i. 要确保产品是依适当的文件所生产与储存，以便获得所需要的质量；ii. to approve the inst

50、ructions relating to production operations and to ensure their strict implementation;ii. 要核准与生产作业有关的指令，并确保其严格的实施；iii. to ensure that the production records are evaluated and signed by an authorised 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之前是经由被授权人员的评估与签名；iv.

51、 to check the maintenance of his department, premises and equipment;iv 要检查生产部门、厂房设施及设备的维护保养； v. to ensure that the appropriate validations are done;v. 要确保做到适当的验证；vi. to ensure that the required initial and continuing training of his department personnel is carried out and adapted according to need.v

52、i. 要确保生产部门的人员已经执行所需要的起始与持续培训，并且依需求做好调适。2.6. the head of the quality control department generally has the following responsibilities:2.6. 质量控制部门的主管一般具有下列责任:i. to approve or reject, as he sees fit, starting materials, packaging materials, and intermediate, bulk and finished products;i. 在他（她）认为合适时核准或拒用

53、原料、包装材料、半成品/中间产品、待分/包装产品和最终产品；ii. to evaluate batch records;ii 评估批次记录；iii. to ensure that all necessary testing is carried out;iii. 确保已执行所有必需的试验iv. to approve specifications, sampling instructions, test methods and other quality control procedures;iv. 核准规格、取样指令、检验方法和其它的质量控制程序；v. to approve and monit

54、or any contract analysts;v. 核准及监督任何受托检验者；vi. to check the maintenance of his department, premises and equipment;vi. 检查质量控制部门、厂房与设备的维护保养；vii. to ensure that the appropriate validations are done;vii. 确保已做到适当的验证；viii. to ensure that the required initial and continuing training of his department personn

55、el is carried out and adapted according to need. other duties of the quality control department are summarized in chapter 6.viii. 确保质量控制部门的人员巳经执行所需要的起始与持续培训，并依需求做好调适。质量控制部门的其它职责摘述于第六章。2.7. the heads of production and quality control generally have some shared, or jointly exercised, responsibilities

56、relating to quality. these may include, subject to any national regulations:2.7. 生产和质量控制的主管，关于质量，通常会有一些分担的或者是共同承担的责任。依我国国家法规的控制，这些职责包括： the authorization of written procedures and other documents, including amendments; - 书面程序和其它文件的核准，包括修订在内； the monitoring and control of the manufacturing environmen

57、t; - 制造环境的监督与控制； plant hygiene;- 工厂卫生； process validation;- 制程验证； training; - 教育培训； the approval and monitoring of suppliers of materials; - 原物料供货商的核准和监督； the approval and monitoring of contract manufacturers; - 受托制造厂的核准和监督； the designation and monitoring of storage conditions for materials and prod

58、ucts; - 原物料和产品之储存条件的指定和监督； the retention of records; - 记录的保存； the monitoring of compliance with the requirements of gmp;- 遵循药品生产质量管理规范之要求的监督； the inspection, investigation, and taking of samples, in order to monitor factors which may affect product quality. - 样品的查核、调查与抽取，以便监督可能会影响产品质量的因素。training培训 2.8. the manufacturer sho