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.

One strain of PRRSV was isolated from tissue of piglets died of obvious respiratory syndrome and high fever.It was identified as a strain of American type PRRSV by serological test and gene sequencing.According to American type PRRSV VR-2332,we designed 3 pairs of primers to aim directly at N gene,GP5 gene and variation sequence of NSP2.The results of sequence analysis indicated a discontinuous deletion of 30 amino acids in nonstructural protein 2 (NSP2).N and GP5 gene is conservative relatively.