论文部分内容阅读
制药行业的厂房设施是实施药品生产质量管理规范(GMP)的关键因素。2010版GMP对厂房设施的要求从标准上基本同欧盟和WHO的要求一致,如何建设一个符合新版GMP厂房和设备,采用哪种方式更为经济、适用?这是我们每个企业负责人、生产管理负责人、质量管理负责人及我们的工程人员都关心的问题。如何启动项目,控制整个施工质量,本文从厂房前期设计到厂房施工过程总结一些新建项目策略。
Plant facilities in the pharmaceutical industry are key elements in the implementation of Good Manufacturing Practices (GMP). 2010 GMP requirements for plant facilities from the standard basically the same with the EU and WHO requirements, how to build a line with the new GMP plant and equipment, which way is more economical and applicable? This is each of our business leaders, production The person in charge of management, the person in charge of quality control and our engineering staff are all concerned about the problem. How to start the project and control the entire construction quality, this article summarizes some new project strategies from pre-plant design to plant construction.