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| 个人信息 |
| 姓 名： |
杨译员 [编号]:158 |
性 别： |
男 |
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| 擅长专业： |
科技英语 |
出生年月： |
1984/10/1 |
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| 民 族： |
汉族 |
所在地区： |
浙江 宁波 |
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| 文化程度： |
本科 |
所学专业： |
英语 |
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| 毕业时间： |
39629 |
毕业学校： |
中北大学 |
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| 第一外语： |
英语 |
等级水平： |
专八 |
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| 口译等级： |
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工作经历： |
1 年 |
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| 翻译库信息 |
| 可翻译语种： |
英语 |
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| 目前所在地： |
浙江 宁波 |
| 可提供服务类型： |
笔译、口译、家教 |
| 每周可提供服务时间： |
笔译：周一至周五
口译-家教：周六，周日 |
| 工作经历 |
| 工作时期： |
2008/7/1--2009/3/1 |
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| 公司名称： |
思瑶服装公司 |
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| 公司性质： |
民营企业 |
| 所属行业： |
翻译 |
| 所在部门： |
外贸部 |
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| 职位： |
业务员 |
| 自我评价： |
工作认真踏实，一丝不苟，上手快。 |
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| 笔译案例信息 |
| 案例标题： |
兽药管理GMP翻译 |
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| 原文： |
1.1 Principle. “Quality assurance” is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product. It is the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use. Quality assurance therefore incorporates GMP and other factors, including those outside the scope of this guide such as product design and development.
1.2 The system of quality assurance appropriate to the manufacture of pharmaceutical products should ensure that: （a） pharmaceutical products are designed and developed in a way that takes account of the requirements of GMP and other associated codes such as those of good laboratory practice (GLP)1 and good clinical practice (GCP);
Good manufacturing practices for pharmaceutical products, Part One. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-second report. Geneva, World Health Organization, 1992, Annex 1 (WHO Technical Report Series, No. 823).
(b) production and control operations are clearly specified in a writ¬ten form and GMP requirements are adopted;
(c) managerial responsibilities are clearly specified in job descriptions;
(d) arrangements are made for the manufacture, supply and use of the correct starting and packaging materials;
(e) all necessary controls on starting materials, intermediate prod¬ucts, and bulk products and other in-process controls, calibra¬tions, and validations are carried out;
(f) the finished product is correctly processed and checked, accord¬ing to the defined procedures;
(g) pharmaceutical products are not sold or supplied before the au¬thorized persons (see also sections 9.11 & 9.12) have certified that each production batch has been produced and controlled in ac¬cordance with the requirements of the marketing authorization and any other regulations relevant to the production, control and release of pharmaceutical products;
(h) satisfactory arrangements exist to ensure, as far as possible, that the pharmaceutical products are stored by the manufacturer, dis¬tributed, and subsequently handled so that quality is maintained throughout their shelf-life;
(i) there is a procedure for self-inspection and/or quality audit that regularly appraises the effectiveness and applicability of the qual¬ity assurance system;
(j) deviations are reported, investigated and recorded;
(k) there is a system for approving changes that may have an impact on product quality;
(l) regular evaluations of the quality of pharmaceutical products should be conducted with the objective of verifying the consis¬tency of the process and ensuring its continuous improvement. certified
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| 译文： |
1 质量保证
1.1 原则。质量保证是一个大范围的概念，其中涵盖了包括影响产品质量的个别以及整体的多方面的事项。它是确保药品质量符合既定用途所需要的规程的总体概念。因此质量保证整合了GMP以及其它因素，包括那些在这个规程之外的其他方面，比如产品设计及研制等
1.2 适用于药品生产的质量保证体系应该具备以下条件：
(a)药品的设计及研发需要遵循GMP及其它相关的法典比如药品安全性试验规范（GLP）和优良临床试验规范（GCP）
药品生产和质量管理的要求，部分1. WHO专家委员会关于药物制品的规范。第32份报告。日内瓦。世界健康组织，1992，附件1（WHO技术报告，NO823）
(b) 生产及管理的运行的情况需采用GMP要求清晰地以书面形式详细说明。
（C）管理的责任需在工作职责中清晰地详细说明。
（d）正确的原材料和包装材料的生产，加工，使用需提前做好安排。
（e）所有对原材料，中间产品，批量产品（bulk product）的必要控制及其它的过程中的控制，监测及检查都需要执行。
（f）根据确立的规程对成品进行正确地处理及检查。
（g）在审查人员证明每一批次的产品的生产和管理符合销售的资格以及其他有关药品生产，管理，发行的规则之前，不得出售或提供该药品。
（h）尽可能为药品的生产商，经销商及随后的使用者做好符合要求的药品储藏的准备工作，以使药品质量在其贮存期限中得到保证。
（I）评价质量保证系统的有效性及适用性的自检及质量审查存在一定程序。
（j） 对于出现的偏差要报告、研究及记录。
（k）对于可能对产品质量产生影响的可认定的变化存在一定的系统。
（l）对于药品质量常规的评估应该是以验证进程的连贯性、一致性以及确保对其进行连续的改进为目的。
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