Frequently Asked Questions - GlaxoSmithKline, ID Biomedical, Sainte-Foy Facility - Posting of Health Canada June 2014 Inspection Summary Report

Q.1 What did Health Canada find during its June 2014 inspection of the ID Biomedical, Ste-Foy facility?

Health Canada carried out a regularly scheduled Good Manufacturing Practices (GMP) inspection at the ID Biomedical facility in Sainte-Foy, Quebec, from June 16-20, 2014. This facility is licensed by Health Canada to manufacture seasonal flu vaccines. Three vaccines are approved in Canada. Fluviral^® has been used in Canada in past flu seasons and is the only one currently on the market in Canada. The other two, FluLaval^® Tetra and Fluviral^® (different formula) are not yet on the market in Canada.

Health Canada identified 10 areas in the facility's Good Manufacturing Practices (GMP) where improvements were required. None of the observations identified, which related to some of the manufacturing and quality control systems in place, affect the safety or quality of the product currently available to Canadians or pose a risk to the health and safety of Canadians. A compliant rating was given to the facility, but a term and condition will be added to the Establishment Licence requiring that the company inform Health Canada prior to resuming production activities for the two vaccine products not yet marketed in Canada.

The company must submit a corrective action plan to Health Canada by August 4, 2014, outlining how the observations identified during the inspection will be addressed.

Health Canada will continue to monitor the safety and quality of the manufacturing processes at the Sainte-Foy facility. If at any time conditions or practices are identified that may result in a potential risk to health and safety of Canadians, Health Canada will take action, as appropriate.

For more details about the inspection, please refer to the posted summary report on Health Canada's website.

Q.2 What were the findings from Health Canada's 2012 GMP inspection of this facility?

Health Canada's 2012 regular GMP inspection of the Sainte-Foy facility concentrated on the laboratory activities. This included assessing how solutions were prepared, how vials were filled and labelled, and visual inspections of finished products.

The inspection did not identify any critical observations that would affect the safety or quality of the product currently available to Canadians, or pose a risk to the health and safety of Canadians.

A corrective action plan was submitted by the company to respond to the observations identified during the inspection.  This plan was reviewed by Health Canada and was found to address the observations in an adequate and timely manner.  A compliant rating was issued to the facility on July 20, 2012. For more information regarding the 2012 inspection, please refer to the posted summary report on Health Canada's website.

Q.3 What were the U.S. FDA findings of this facility?

For more information on this U.S. FDA inspection, please refer to their warning letter issued to the company, available on the  FDA website.

Q.4 How did Health Canada's inspection and findings compare to those of the U.S.?

In developing its June 2014 inspection plan, Health Canada inspectors reviewed a variety of information including past inspection documents, as well as quality and manufacturing documents specific to the facility to be inspected. Health Canada inspectors modified their inspection to review the U.S. FDA's findings and the status of implementation of ID Biomedical Corporation of Quebec's corrective action plan and commitments. Due to the short timeframe between the U.S. FDA and Health Canada inspection, ID Biomedical Corporation of Quebec was unable to implement all of the corrective actions it proposed in response to the U.S. FDA observations before the start of the Health Canada inspection. At the conclusion of the inspection, Health Canada's observations were similar to those noted by the U.S. FDA. Health Canada inspectors were satisfied with ID Biomedical of Quebec's responses to the U.S. FDA, with the exception of those related to a new manufacturing process, for which Health Canada has imposed a term and condition on ID Biomedical's establishment license so that Health Canada can assess whether the company has been able to put acceptable levels of controls in place. Health Canada will continue to exchange information and results with the U.S. FDA on the GMP practices at the ID Biomedical Corporation of Quebec.

Q.5 Will the inspection findings and term and condition have any impact on the timing and delivery of seasonal flu vaccine?

ID Biomedical has informed the Public Health Agency of Canada that it does not expect the adjustments it has made to its manufacturing process to significantly affect availability of flu vaccine this fall.

ID Biomedical has provided assurances that it will continue to update government officials regularly.

As a precaution, the Agency is working with other vaccine suppliers in the unlikely event there is a delay.

Canada has existing contracts in place with three other influenza vaccine manufacturers and these contracts do provide opportunities to increase supply if necessary - either to meet an increase in demand or to offset reduced supply should one supplier experience production challenges.