Inspectorate Ottawa

The Inspectorate Ottawa is responsible for the coordination and planning of the Health Products and Food Branch (HPFB) Inspectorate's investigation, inspection, establishment licensing, and emergency preparedness functions, policy and strategic planning, and operational planning and information management. It accomplishes these aims by ensuring effective communication, coordination and issue resolution with regional operational centres, HPFB directorates and offices, regulatory authorities and stakeholders.

The Inspectorate Ottawa is comprised of four areas, each with a Director who is accountable to the Director General. These are:

The Office of the Associate Director General, whose responsibilities include moving forward Inspectorate strategic priorities, and liaising with other Directorates, other Branches and the office of the Assistant Deputy Minister.

The Compliance & Enforcement Coordination Division, whose responsibilities include the management of risks and emergency response and the coordination of the planning and delivery of the Inspectorate's core compliance and enforcement functions, including:

• Drug Good Manufacturing Practices (GMP) Inspection Unit, which coordinates Inspectorate activities regarding compliance with GMP in establishments manufacturing, testing, distributing, wholesaling or importing drug products;
• Drug Compliance Verification & Investigation Unit, which coordinates compliance verification and investigation activities in the area of drug products including natural health products;
• Medical Devices Compliance Unit, which coordinates the compliance verification and investigation of medical device incidents and complaints, the review of medical device mandatory problem reports and the inspection of medical device establishments.
• Blood, Tissues, Organs and Xenografts (BTOX) Compliance Unit, which coordinates the inspection, compliance verification and investigation of establishments that manufacture, process, store or import human blood, cells/tissues/organs, and donor semen;
• Good Clinical Practices (GCP) Unit, which coordinates the inspection, compliance verification and investigation activities related to drugs used in clinical trials, at Sponsors, Qualified Investigators and Research Ethics Boards.

The Processes, Services and Systems Division, includes:

• Establishment Licensing Unit, which manages the issuance of Drug and Medical Device Establishment Licenses and export certificates based on World Health Organization (WHO) standards.
• Operational Planning & Information Management Unit, which is responsible for operational planning and financial reporting, performance management, records management, and document system management and database support.
• Emergency Preparedness Coordination

The Policy and Strategic Planning Division, whose responsibilities include:

• policy development and advice to the Director General and Inspectorate Management Committee
• regulatory affairs
• coordination of the Inspectorate's participation in international activities and issues, and
• strategic planning.