7-Henry Tjong-设计确认.pdfVIP

Design Qualification 设计验证 Speaker: Henry Tjong （张诚汝） September, 2009 Design Qualification 设计验证 Mr. Henry Tjong is a Senior GMP Consultant, works in the Healthcare Process Department, Bayer Technology and Engineering (Shanghai) Co. Ltd. 张诚汝先生任职于拜耳技术工程（上海）有限公司，他是医药保健工艺部门的高级GMP顾 问。 He is a dedicated and focused Professional Engineer with 26 years of progressive engineering/project/validation experience, including more than 20 years in the biotechnology and pharmaceutical fields. 一个在国际制药业具有丰富工程管理和验证经验的专家和项目经理，在制药行业从事工程 管理和验证工作长达20年。 Title Author 2008-04-06 • Page 2 Design Qualification 设计验证 In a pharmaceutical engineering project, design is complicated due to the complex nature of engineering project and in addition, to fulfill the GMP requirements. Design quality, will highly impact the quality, schedule and cost of a project, and ultimately the GMP compliance of the facility. 在制药工程项目中，设计是很复杂的，这是由于工程项目的内在复杂性及附加 的GMP的要求。设计的质量直接影响着项目的质量，时间及费用，及最终设施 的GMP符合性。 Title Author 2008-04-06 • Page 3 设计是复杂的 Title Author 2008-04-06 • Page 4 Design Qualification 设计验证 Systematic design review is a must to ensure design quality and a requirement of Good Engineering Practice. The importance of this activity is reflected in many regulations, for example, EMEA GMP, ICH, and PIC/S etc requires Design Qualification. In China, in the new GMP under discussion, DQ is required as the first step of the qualification practices. 系统的设计审核对于保证设计的质量是至关重要的，并且也是良好工程规范的 要求。这一活动的重要性还进一步地体现在很多监管条例上，如欧盟的GMP， ICH，及PIC/S中都要求设计确认。在中国，新版的GMP讨论稿中，也要求设 计确认作为整个确认活动的起点。 Title Author 2008-04-06 • Page 5 Design Qualification 设计验证 BTES as an International Engineering Company provides technology and engineering services to pharmaceutical industry worldwide. Through this presentation, we would like to share some of our knowledge and experiences; hopefully we would help the local pharmaceutical companie