Published: December 2008
Good Engineering Practices (GEPs) consist 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 in the day-to-day operations and forward planning of a pharmaceutical business. The adoption of this methodology leads to a balance of expenditure and activity. In addition, GEP documentation can be leveraged to support verification work. This Guide brings a wealth of information on GEPs and provides benchmarking tools of current company practices against what is considered industry good practice.
The ASTM standard (E2500) builds on the concepts of GEPs and has substantial implications for reductions in cost and time for pharmaceutical capital investment projects.
This first edition of the ISPE Good Practice Guide: Good Engineering Practice covers the complete lifecycle of engineering from concept to retirement. The Guide:
The Guide divides GEP activity into three sections each prefaced with the definition of the practice. Within each section, common practices and sub-practices are identified to provide illustrative examples of GEP.
Project Engineering, including
Common Practices, including
Operation and Maintenance, including
This globally-reviewed document was developed through the collaboration of professionals from various sectors and geographic regions of the pharmaceutical industry with the intention of determining a common understanding of the concept and principles of GEP.