ISPE Good Practice Guide: Good Engineering Practice

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:

• Aims to promote a common understanding of the concept and principles of GEP defines and explains the term "Good Engineering Practice"
• Describes the fundamental elements existing in pharmaceutical and related industries
• Identifies practices, demonstrating how GEP concepts may be applied in the pharmaceutical industry considering the entire range of pharmaceutical engineering activity
• Identifies key attributes of GEP, including how GEP relates and interfaces with GxP

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

• Project Infrastructure
• Project Organization
• Value Analysis
• Planning and Monitoring
• Design Reviews
• Handover

Common Practices, including

• Standards and Procedures
• Documentation Practices
• Change Management
• Innovation and Continuous Improvement

Operation and Maintenance, including

• Engineering Manuals and Records
• Breakdown Maintenance
• Internal Audit
• Equipment Decommissioning and Retirement

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.