“Praxis regards this certificate as further validation of our pharmaceutical quality assurance systems,” said Anne Armstrong, Vice President of Quality.
The certificate was issued to Praxis on the basis of a completed GMP inspection in accordance with the European Union (EU) and European Economic Area (EEA) GMP principles and guidelines. Compliance with these principles and guidelines is mandatory within the European Economic Area (EEA).
For products imported from countries outside of the European Union (EU), a supervisory authority is responsible for verifying that the manufacturer conforms to standards of GMP equivalent to those in force in the EU. The EMA's Manufacturing and Quality Compliance Section coordinates GMP inspections of manufacturing sites connected to centrally authorized human medicines.