Patheon® is a leading provider of drug substance and drug product services for the global biopharmaceutical industry. SEE AND Read More »

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Our Approach

We believe quality is fundamental to our business and to the customers and patients we serve. It ensures safe and effective products throughout their life cycle that earn the trust of all consumers. Our Quality System is designed to comply with all customer and applicable regulatory expectations. It consists of business processes embodying problem prevention, reliability and continuous improvement. Personal integrity and the implementation of this Quality Policy are the responsibility of every employee. We will never compromise product quality.

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 Track Record

Due to the nature of our business, Patheon's facilities are audited more than 200 times a year by national and international regulatory bodies as well as customers. As a result of our strong compliance record, Patheon has received approvals for more than 45 pre-approval inspections from 25 countries/regions, and been granted nearly 20 waivers since 2006. Inspecting agencies include:

  • U.S. Food and Drug Administration (FDA), USA
  • European Medicines Agency (EMEA), European Union
  • The Ministry of Health, Labor and Welfare, Japan
  • Health Products and Food Branch Inspectorate (HPFBI) and Therapeutic Products Directorate (TPD), Canada
  • 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 Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • U.S. Drug Enforcement Administration (DEA), USA
  • Inspectorate Deutschland, Germany

While some may view regulatory supervision as a hurdle, Patheon views it as an impartial measure of excellence. Since August 2006, our facilities have undergone 221 regulatory agency inspections, with 45 resulting in zero observations. Nearly 1 in every 5 regulatory inspections has resulted in zero observations. While we are certainly proud of this regulatory track record, that doesn't stop us from constantly striving to perform even better.

Global EH&S Policy

We are committed to the health and safety of our employees and the protection of the environment. Our environment, health and safety culture is based on the philosophies of prevention and continuous improvement. We respect and follow the laws and regulations of the jurisdictions in which we operate. We actively seek out and consider expert recommendations towards meeting or exceeding industry best practices. We strive to minimize our impact on the environment by conserving our natural resources and behaving in an environmentally responsible manner. Management and Supervisors are accountable for the health and safety of those under their supervision. Every employee is responsible for his or her own health and safety and for maintaining a safe workplace.

Please click here to see additional details on our EH&S Program and Goals.

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