我国医药工程项目建设亟需规范管理

Necessity of Regular Administration of Pharmaceutical Engineering Project in China

医药工程建设质量是实施GMP的可靠保证,推行GMP必须从源头抓起。我国目前医药工程建设管理相当薄弱,使工程质量存在潜在危险。国外试行的GEP秉承了GMP的理念,运用全过程控制的思维方式,为确保工程项目符合GMP要求提供了有力支持,对医药工程项目建设具有重要指导意义。我国医药工程建设需要GEP管理。

The quality of pharmaceutical engineering construction is the reliable guarantee of GMP realization. It is necessary to focus on the fundamental points in propagating GME In our country, currently, the administration of pharmaceutical engineering construction is quite weak, which makes the quality of engineering has hidden risks. The trial practice of GEP in abroad inherits the principles of GMP, which includes the model of whole procedure control and supply the solid support to fulfill the requirements of GME The practice of GEP has important guiding meaning in pharmaceutical project construction. The pharmaceutical engineering construction in our country requires GEP management.