Effective project progress, monitoring, and control are not regulatory issues, but are necessary for the efficient operation of a company and part of Good Engineering Practice (GEP). This course considers the entire range of pharmaceutical engineering activity and identifies key attributes of GEPs consisting of proven and accepted engineering methods, procedures, and practices that provide appropriate, cost-effective, and well-documented solutions to meet user-requirements and compliance with applicable regulations.
GEP underpins activities of daily operations and forward planning of a pharmaceutical business and the adoption of GEP methodology can lead to a balance of expenditure and activity. The scope of GEP covers the complete life cycle of engineering from concept to retirement and provides a foundation required across the pharmaceutical industry upon which other areas, such as GxP, build. In addition, GEP documentation can be leveraged to support verification work. This course also utilizes benchmarking tools from company practices against what is considered industry good practice.