Pharma Techexplained
Glossary

GxP

The family of good practice regulations: GMP for manufacturing, GLP for laboratories, GCP for clinical trials, and their siblings.

The x is a placeholder: manufacturing (GMP), laboratory (GLP), clinical (GCP), distribution (GDP), pharmacovigilance (GVP) and more. What unites them is the premise that quality must be built into the process and proven with records, not inspected in afterward.

When a system is described as GxP-relevant, it means the system touches data or decisions that one of these regulations cares about, which is the trigger for validation, data integrity controls and all the rest of the apparatus this glossary describes.