GxP indicates a summary of all the guidelines for "good working practice", which is significant in medicine, pharmacology and pharmaceutical chemistry in particular. The "G" stands for "Good" and the "P" for practice, while the "x" in the middle is replaced by the respective abbreviation for the specific area of application.
We at Berlinger & Co AG also apply these guidelines to our development and manufacturing processes, as well as to processes outsourced to our subcontractors.
GxP includes the following amongst others:
- Good Agricultural Practice (GAP)
- Good Manufacturing Practice (GMP)
- Good Distribution Practice (GDP)
- Good Clinical Practice (GCP)
- Good Clinical Laboratory Practice (GCLP)
- Good Laboratory Practice (GLP)
- Good Automated Manufacturing Practice (GAMP)
- Good Documentation Practice (GDP)
- Good Engineering Practice (GEP)
- Good Pharmacovigilance Practice (GVP)
These guidelines are stipulated amongst others by the European (European Medicines Agency) and American (Food and Drug Administration, FDA) public health authorities. In Germany, the supervisory authorities in the Federal states are responsible for monitoring compliance with the guidelines.