Summary Report - ID Biomedical Corporate of Quebec (GSK)

Company and Product Information

ID Biomedical Corporation of Quebec is a subsidiary of GlaxoSmithKline [GSK]. The facility is located in Sainte-Foy, Quebec, and it manufactures five (5) different types of seasonal flu vaccine for the global market, three (3) of which have been approved in Canada. However, only one (1) is currently marketed in Canada.

Background

All health products made in Canada must meet high standards for safety and quality before they can be sold to Canadians. Inspections of Good Manufacturing Practices (GMPs) are an important part of ensuring that these standards are being met.

Health Canada inspects facilities like ID Biomedical Corporation of Quebec every two years to verify compliance with internationally recognized GMP standards. For each of these inspections, a plan is developed. In developing such plans, Health Canada inspectors review a variety of information including past inspection documents, as well as quality and manufacturing documents specific to the facility to be inspected. Plans identify key areas for compliance verification, based on risk, as inspections cannot assess every manufacturing process during the limited time in the facility.

Provided below are summaries of the 2012 and 2014 Health Canada inspections of ID Biomedical Corporation of Quebec (GSK).

2012 Inspection:

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

While the inspection did not identify any critical observations (classified as risk 1) that required immediate action to protect the health and safety of Canadians, it did identify two major observations (classified as risk 2) related to staff practices in areas that are maintained in such a way as to restrict the growth of microorganisms in the environment, prevent contamination and ensure sterility. Inspectors made other observations (classified as risk 3) that were related to incomplete standard operating procedures, analysis methods, and minor deficiencies in the visual inspection program.

The facility was given an overall compliant rating based on the review of all observations made during the inspection. As part of the normal inspection process, the facility submitted a corrective action plan to respond to the observations. Health Canada reviewed the plan and found it addressed the observations in a timely manner to the Department's satisfaction. Assessment of the implementation and effectiveness of these corrective measures were verified during the 2014 inspection.

June 2014 Inspection:

Based on a regular two-year GMP inspection cycle, Health Canada planned to inspect the ID Biomedical facility again in June 2014.

Inspection Planning

While planning for this inspection was under way, an April 2014 United States Food and Drug Administration (U.S. FDA) inspection of the same facility noted several significant deviations from GMP standards. The results of this inspection were shared with Health Canada. Health Canada reviewed ID Biomedical Corporation of Quebec's corrective action plan and commitments to the U.S. FDA. The Health Canada inspection plan for 2014 was amended to include follow-up on the implementation of the corrective actions associated with the U.S. FDA inspection observations.

During its June 2014 inspection of the ID Biomedical Corporation of Quebec facility, Health Canada looked at overall quality and manufacturing activities with a particular focus on the initial phases of the manufacturing activities. These activities include the preparation of raw materials that ultimately may be used in the manufacturing of finished products.

Summary of Observations

Based on the review of all observations made during the inspection, an overall compliant rating was given. However, inspectors identified 10 areas where improvements were required. It is important to note that it is not unusual for a given GMP inspection to result in a number of observations that require corrective action. Production processes are complex and GMP safety and quality standards are very high. Given the size of the facility and complexity of the production process, this number of observations is considered acceptable. None of the observations were critical (risk 1), the most serious category. Seven (7) observations were identified as major (risk 2) and three (3) observations were classified as other (risk 3).

Manufacturing Controls

Some risk 2 observations regarding elements of the manufacturing processes at the facility were documented during this inspection. These elements pertain to the new manufacturing process for the two (2) vaccines not yet marketed in Canada. Health Canada requested that additional actions be taken to address the root cause of the issues as the corrective actions implemented by the facility did not address these issues to the satisfaction of Health Canada inspectors. In order to help ensure Canadian supply requirements of seasonal influenza vaccine for 2014-15 were met, the company reverted to the former process which had been in place at the time of the 2012 inspection and had been used to safely produce vaccine for several years.

It was observed that previous changes made to the water quality systems did not address reoccurring issues with respect to microbial contamination. An additional observation related to the efficacy of one of the disinfecting products used to cleanse certain microorganisms which had not been assessed regularly.

Quality Control Systems

Observations regarding the management of some quality control systems were also noted.An observation pertained to the management of the environmental program for the production areas and the need for improvement to ensure that they are sterile at all times. It was noted that a piece of filling equipment was not being sufficiently monitored to detect microbial levels. There were also gaps in how complaints concerning potentially defective products were evaluated and investigated. In addition, deficiencies were noted in the way the facility documented what the impact of deviations from established procedures or standards was on the quality of the products. Lastly, the facility runs a simulation of its production line. It was noted that the facility did not compare the rejection rate between the actual product line and the simulation.

Conclusions & Next Steps

The 2014 inspection did not identify any deviations that would affect the safety or quality of the product to be supplied, nor pose a risk to the health and safety of Canadians. As a result, a compliant rating was given.

Health Canada inspectors made observations similar to those mentioned in the U.S. FDA report. Due to the short timeframe between the U.S. FDA and the 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 initiation of the Health Canada inspection. 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.

ID Biomedical Corporation of Quebec has been cooperative throughout the inspection process, moving quickly to address the observations of the inspectors. GSK is requested to provide by August 4, 2014 its corrective action plan to Health Canada to outline how it will address all of the observations identified at the time of the Health Canada inspection. Health Canada will actively monitor the implementation of the action plan at the Sainte-Foy facility.

As is the case in other major jurisdictions such as in the United States and Europe, Canadian vaccines are subject to an ongoing lot release evaluation after approval. For each lot of vaccine to be sold in Canada, the manufacturer must submit the results of its own testing as well as samples for independent testing and evaluation by Health Canada. Only lots that have passed the Health Canada testing are permitted to be released for use in immunization. This Lot Release Program provides an additional check on vaccines to help ensure that each lot or batch is safe for human use.

Furthermore, Health Canada has imposed one "term and condition" that has been added to the facility's establishment licence. This will require that the facility inform Health Canada ninety (90) days before resuming production activities for the two (2) vaccine products that are not currently on the market in Canada. This will allow Health Canada to take any further actions deemed necessary at the time.

If at any time conditions or practices are identified that may result in a potential risk to health, Health Canada will take immediate and decisive action to protect the health and safety of Canadians.