Regulatory Experience

Patheon has a well-established record of success in meeting the standards of global regulatory agencies and customers.  As a result of our global presence, Patheon facilities have been inspected by a large number of international regulatory agencies, including:

• Food and Drug Administration (FDA), USA
• Health Products and Food Branch Inspectorate (HPFBI), Therapeutic Products Directorate (TPD), Canada
• European Medicines Agency (EMEA), European Union
• Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
• Agência Nacional de Vigilância Sanitária (ANVISA), Brazil
• Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS), France
• Gulf Cooperation Council (GCC),  United Arab Emirates, Bahrain, Saudi Arabia, Oman, Qatar, Kuwait
• Agenzia Italiana del Farmaco (AIFA), Italy
• The Ministry of Health, Labor and Welfare, Japan

In addition, two of Patheon’s facilities are also accredited under the International Standard’s Organization ISO9000 and ISO13485 standards.

Audit History

Due to the nature of our business Patheon's facilities are frequently audited by national and international regulatory bodies and customers. In fiscal year 2007 alone, Patheon facilities completed a combined total of more than 200 regulatory and customer audits.

Since 2000, Patheon has partnered with our customers to receive approvals for more than 35 pre-approval inspections.   In addition and as a result of our strong compliance record Patheon has also been granted more than 20 waivers since 2000.

Customers that have audited Patheon include 19 out of the top 20 pharmaceutical companies in the world for whom Patheon manufactures products.  Patheon welcomes these audits as they provide us insight into industry trends and allow us to continually improve our operations and quality systems.