Good Manufacturing Practice (GMP) is an EU and worldwide standard that was developed by the Food and Drug Administration (FDA), which is a United States agency that is responsible for approving medicines and foodstuffs and promoting health, which is implemented by the European Union member states. Its objective is to ensure the cleanliness, safety and high efficacy of medicinal products, medical devices and processes in place within the company.
GMP standards apply to the manufacturing process, staff qualifications, archiving analytical results and control and distribution processes. The system is based on three pillars: first: procedures, second: training, third: internal audits. Only when all of the three modules are in place is the system deemed fully implemented.