Medical Surveillance Program for NRC - Clinical Trial Material Facility - CTMF

To perform timely and ongoing health evaluations, as required, for identified staff from the
NRC-Clinical Trial Material Facility (NRC-CTMF) in accordance with the NRC-CTMF Medical
Surveillance Program.

The NRC has established a new Good Manufacturing Practices (GMP)-compliant Clinical
Trial Material Facility (CTMF) at its Royalmount Avenue site in Montréal. This facility will
produce vaccines and other biologic materials for clinical trials on behalf of NRC partners
and collaborators, supporting Canada’s biomanufacturing capacity and pandemic
preparedness.

Accordingly, the CTMF Quality System requires the implementation of a Medical Surveillance
Program, as outlined in a Standard Operating Procedure (SOP), to ensure product safety. This
program ensures that all personnel accessing the facility meet the minimum health
requirements aligned with their operational duties.
The procedure covers the verification, documentation, and confirmation of the personnel
fitness to access production areas and/or perform assigned tasks through medical
assessments conducted by designated healthcare professionals at an Occupational Health
Center (OHC). It also includes additional health evaluations following any reported illness or
injury.