3.1 What is GxP?

Quality in the biotech/pharmaceutical industry is defined in GxP guidelines which generally stands for good working practices in different disciplines. It includes:

• GLP – Good Laboratory Practice

• GCP – Good Clinical Practice

• GMP – Good Manufacturing Practice

• GDP – Good Distribution Practice

• GVP – Good Vigilance Practice

Often it is also called cGxP, where the c stands for “current”.

In the context of CMC development, primarily GMP and for supply chain/distribution primarily GDP are relevant.