Application of Good Engineering Practice in rabies vaccine engineering projects
10.13200/j.cnki.cjb.004214
- VernacularTitle:良好工程实践在狂犬病疫苗工程项目中的应用
- Author:
GAO Enpeng
- Publication Type:Journal Article
- Keywords:
Good Engineering Practice(GEP);
Biopharmaceutical engineering;
Risk management;
Organization and control;
Cost management;
Innovation and continuous improvement
- From:
Chinese Journal of Biologicals
2024;37(5):513-518+526
- CountryChina
- Language:Chinese
-
Abstract:
Good Engineering Practice(GEP)is an engineering practice specifically designed for pharmaceutical engineering projects,aimed at ensuring product quality,patient safety,and Good Manufacturing Practice of Medical Products(GMP).Based on the existing management system,biopharmaceutical engineering,and international engineering project management models of Changchun Institute of Biological Products Co.,Ltd.(referred to as CCIBP),as well as combined with the characteristics of GEP technology,this paper summarizes the construction of GEP system of CCIBP and its application in rabies vaccine engineering projects starting with the key control points such as User Requirement Specification(URS),plan,design,change,quality,and handover,so as to provide technical support and theoretical references for vaccine engineering projects in risk management,organization and control,cost management,innovation and continuous improvement.
