Health Canada announces results of Emergent BioSolutions facility inspection
Update – March 31, 2022
Based on new information received from Janssen after the fall 2021 on-site inspection, Health Canada has assigned the Emergent BioSolutions facility a non-compliant rating. This means that Canada will not accept any products or ingredients made at this facility unless Janssen requests to add the Emergent BioSolutions facility to its Health Canada licence and Health Canada determines that the facility meets Good Manufacturing Practices requirements. There are no products from this facility on the Canadian market and none of the Janssen COVID-19 vaccines available in Canada or intended for international donation contain ingredients made at this facility.
November 24, 2021 | Ottawa, ON | Health Canada
Health Canada has completed its onsite inspection of the Emergent BioSolutions facility in Baltimore, Maryland. The European Medicines Agency and South African Health Products Regulatory Authority also participated in this inspection remotely. All three regulators found the facility to be compliant with Good Manufacturing Practices (GMPs).
GMPs are an internationally recognized quality assurance system used to ensure that drugs and vaccines are made, packaged, labelled, tested, stored, imported and distributed using consistent standards.
In June 2021, Health Canada communicated that Canada would not accept any product or ingredients made at the Emergent BioSolutions facility until the Department completed an onsite inspection. This facility manufactures the drug substance used in some doses of the Janssen (Johnson & Johnson) COVID-19 vaccine.
Health Canada’s compliant rating means that Janssen Inc. will be able to import their vaccines into Canada that are made with the drug substance manufactured at the Emergent BioSolutions facility.
While there are no further shipments of the Janssen vaccine planned at this time, the Government of Canada will continue working with provinces and territories to identify any further doses that may be required. As with all vaccines, each lot of the Janssen COVID-19 vaccine that could potentially be imported into Canada or donated on Canada’s behalf will be assessed to confirm that it meets Health Canada’s stringent safety and quality requirements. Only vaccine lots that meet these requirements will be released onto the Canadian market or provided as a Canadian donation.
The shipment of Janssen vaccines that Canada received on November 10 came from compliant manufacturing sites in Europe.
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