ISPE Good Practice Guide: Good Engineering Practice

by ISPE

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.

Paperback

Published January 1, 2008