| Good Engineering Practice (GEP) | A combination of standards, specifications, codes, regulatory and industrial guidelines as well as accepted engineering and design methods intended to design, construct, operate, and maintain pharmaceutical and/or biotechnology facilities taking into account not only regulatory compliance but also safety, economics, environmental protection and operability. Standards and specifications are provided by recognized sources such as established engineering and architectural contractors as well as pharmaceutical companies. Codes are provided by local, state, or federal jurisdictions and/or insurance companies. Guidelines are issued by professional societies, industrial organizations, or regulatory agencies. Engineering design methods have been established throughout the engineering educational system. |
