GxP is a general abbreviation for the "good practice" quality guidelines in regulated industries such as food, drugs, bio products, medical devices, and cosmetics. For example, the guideline for computer system validation is called GAMP®5 (5th version of Good Automated Manufacturing Practice). There are some other ‘good practice’ guidelines with the purpose of ensuring a product or service is safe and meets its intended use, such as:
- GAP (Good Agricultural Practice)
- GCLP (Good Clinical Laboratory Practice)
- GEP (Good Engineering Practice)
These guidelines all involve a combination of planning, implementation, monitoring, auditing, and continuous improvement. The applicable target product goes beyond computer systems, but a similar approach applies.
GxP validation is the process of establishing documentary evidence showing that systems, equipment, and processes meet regulatory requirements, maintain data integrity, and produce consistent and reliable results. Computer system validation is one type of GxP validation.