Medical Surveillance Program for NRC - Clinical Trial Material Facility - CTMF - Amendment 1

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.