3. Key GxPs in Medicine
1. Key GxPs in Medicine
Patients expect medicines to be safe, effective, of high quality and accessible.
The most relevant GxPs in the pharmaceutical industry are:
- Good Laboratory Practice (GLP)
- Good Clinical Practice (GCP)
- Good Manufacturing Practice (GMP)
- Good Pharmacovigilance Practice(GVP)
- Good Distribution Practice (GDP)
- Good Documentation Practice (GDocP)
The extent of what GxPs are included in a GxP system often depends on the respective jurisdiction, but GLP, GCP and GMP are always comprised as a minimum. Further, in the legislation some GxPs are subsumed under another GxP, e.g. Good documentation practice (GDP) can be found under Good manufacturing practice (GMP).
Figure 1 below is a high-level overview of Key GxPs along the medicines R&D process. Of note: the Good Lay Summary Practice GLSP is included here among the Key GxPs because it is of particular interest for patients/patient advocates.
Figure 1: High-level overview of Key GxPs along the medicines R&D process