By Patrick Chen, Quality Engineer, Bora Pharmaceuticals
GxP is a general term used to describe the quality guidelines and regulations applied in the pharmaceutical industry. GxP is the abbreviation of “Good x Practice”. The “x” in GxP stands for the field the guidelines and regulations applied to.
Here are examples of GxPs often seen in the pharmaceutical industry:
- GMP - Good Manufacturing Practice
- GLP - Good Laboratory Practice
- GDP - Good Distribution Practice
- GCP - Good Clinical Practice
Although different regulations are applied in different countries/regions, the fundamental concept of GxP is similar across the globe. In the US, GxP regulations are defined in the Code of Federal Regulations (CFR) Title 21. In the EU, GxP regulations are defined in EudraLex. In many countries, the PIC/S (Pharmaceutical Inspection Co-operation Scheme) GMP and the ICH (The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use) guidelines are adapted.