what is gxp in pharma

1 year ago 84
Nature

GxP is an abbreviation for "Good x Practice" where the "x" denotes various disciplines, including disciplines within the pharmaceutical industry. GxP is a set of rules that are required for the safety and quality of pharmaceutical products. In the pharmaceutical sector, the "x" denotes the following areas:

  • Manufacturing
  • Distribution
  • Laboratory
  • Clinical
  • Documentation

GxP ensures that regulated organizations comply with specific and secure manufacturing and storage processes and procedures that determine effective research standards for nonclinical laboratory trials and safe human-subject clinical trials. The guidelines focus on traceability, accountability, and security. GxP compliance is vital in the pharmaceutical industry, and it is a globally recognized standard. The "x" in GxP stands for the field the guidelines and regulations applied to, and examples of GxPs often seen in the pharmaceutical industry include GMP (Good Manufacturing Practice), GDP (Good Distribution Practice), GLP (Good Laboratory Practice), and so on.