Formation GAMP5 – M2

GxPs regulate the process from discovery of a new product to distribution to the market
Quality mana for diverse industries :
- Pharmaceutical
- Food
- Cosmetic

GAMP: Guidance aims to achieve computerized systems that are fit for intended use and meet
current regulatory requirements
Benefits:
- Patient safety
- Product quality
- Data integrity

Computerized systems:
- Software/Hardware : Computer system
- People / procedures / equipment / controlled function & Processes linked by data
Operating environment

Case: Define processes  hospital transportation device