Quality is a fundamental and integral part of our business and yours. At Patheon, quality is not just a department, but what drives us. Our goal is perfection every time in everything we do. With highly trained staff and innovative systems throughout the entire organization, we constantly strive to develop new ways to exceed all regulatory requirements and customer expectations while reducing costs and lead times.
We believe that the higher our quality, the more timely work gets finished, the lower our costs become, and thus the better business partner we are for you the customer. Each Patheon facility has an experienced quality management team who actively collects quality and compliance Key Performance Indicators from sources such as customer and regulatory audits, self inspections, local departmental meetings, trending reports, product and data reviews and non-conformance quality systems monitoring programs. These data are systematically analyzed and regularly reported to senior management, site leadership teams, and to corporate quality and operations management teams. With this vigilant and proactive approach, Patheon is dedicated to maintaining an environment of strict cGMP compliance and continuous improvement throughout our global network.
Additionally, the Patheon Quality Control Laboratory offers a full compliment of testing capabilities to support the manufacturing and release of products. This also includes post market stability monitoring services, and at some sites, analytical development services. We perform a full range of testing including release tests for U.S. Pharmacopeial Convention, European Pharmacopeial and Japanese Pharmacopeial requirements.
Our Stellar Track Record
Due to the nature of our business, Patheon's facilities are frequently audited by national and international regulatory bodies and customers more than 200 times a year. As a result of our strong compliance record, Patheon has received approvals for more than 35 pre-approval inspections and been granted nearly 20 waivers since 2006. Inspecting agencies include:
- Food and Drug Administration (FDA), USA
- Health Products and Food Branch Inspectorate (HPFBI) and 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
Where some may view regulatory supervision as a hurdle, Patheon views it as an impartial measure of excellence. Since 2007 our facilities have undergone 133 regulatory agency inspections, with 31 resulting in zero observations. That's an unheard of nearly 1 in every 4 inspections being perfect. Also, Patheon is the only sterile drug manufacturer with no warnings from regulatory agencies. While we are certainly proud of this regulatory track record, that doesn't stop us from constantly striving to perform even better.