Glossary · GxP: good practices

Good engineering practice (GEP)

Also known as: GEP, Good engineering practices

Good engineering practice (GEP) is the use of established engineering methods and standards across the lifecycle of equipment and facilities to deliver solutions that are appropriate, cost-effective and documented. In the pharmaceutical industry it is described in the ISPE Good Practice Guide: Good Engineering Practice; it is not legally mandated by name but forms the basis on which GMP-critical aspects are then qualified.

GxP
Pharma

In one sentence

GEP is the use of sound engineering methods for pharma equipment and facilities, the basis on which GMP-critical aspects are then qualified.

Example

An engineering firm builds a purified water system to recognized piping and welding standards with design reviews and commissioning records; the manufacturer then qualifies only the aspects critical to water quality and reuses the commissioning records as evidence.

How it applies

Engineering lifecycle: GEP covers planning, design, procurement, construction, commissioning, operation and retirement, with project management, design reviews and engineering change management.
Link to qualification: The science- and risk-based verification approach of ISPE Baseline Guide 5 and ASTM E2500 lets GMP qualification build on GEP documents, so critical aspects are verified once rather than tested twice.
Machinery overlap: Equipment for pharma plants is also machinery; its engineering must meet machinery law, such as the risk assessment under ISO 12100, alongside GMP expectations.
Technical documentation: GEP records — specifications, drawings, commissioning and test records — can serve as qualification evidence only if they are controlled documents with clear authorship, review and dates.

GEP vs. GMP

GEP asks whether equipment is engineered well; GMP asks whether it is fit to make a medicinal product of the required quality. Everything is engineered under GEP; only the aspects that affect product quality, patient safety or data integrity also need GMP qualification under Annex 15.