Health Canada Rates GSK’s Influenza-Manufacturing FacilityBy
Health Canada, the national regulatory authority of Canada, issued a summary report of its inspection conducted in June 2014 of ID Biomedical Corporation’s, a subsidiary of GlaxoSmithKline, manufacturing facility located in Sainte-Foy, Quebec. The facility manufactures five different types of seasonal flu vaccine for the global market, three of which have been approved in Canada and only one that is currently marketed in Canada. Based on its most recent inspection in June 2014, Health Canada issued a compliant rating but noted 10 areas where improvements were required. This follows the issuance of a Warning Letter by the US Food and Drug Administration that was issued in June 2014.
“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.” said Health Canada in its report. “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 observations were identified as major (Risk 2) and three observations were classified as other (Risk 3).
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 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. To help ensure Canadian supply requirements of seasonal influenza vaccine for 2014-2015 were met, the company reverted to the former process that 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.
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.
“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,” said Health Canada in its report.
Health Canada said its inspectors made observations similar to those mentioned in the FDA report. On June 12, 2014, GSK received a Warning Letter from the FDA relating to a FDA inspection carried out in early April 2014 at the influenza vaccine-manufacturing facility in Saint-Foy. Due to the short timeframe between the and the Health Canada inspection, ID Biomedical was unable to implement all of the corrective actions it proposed in response to the FDA observations before the initiation of the Health Canada inspection. Health Canada said it will continue to exchange information and results with the FDA on the GMP practices at the ID Biomedical Corporation of Quebec.
Health Canada said “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 said it will actively monitor the implementation of the action plan at the Sainte-Foy facility. Health Canada has imposed one “term and condition” that has been added to the facility’s establishment license that will require that the facility inform Health Canada ninety days before resuming production activities for the two 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.
“As noted in Health Canada's Summary Report, through an amendment to the terms and conditions of our Establishment License proposed by Health Canada on July 8, 2014, the agency now requires 90 days advance notice should we resume production of Fluviral (DIN 20420686) and FluLaval Tetra (DIN 02420783) for the Canadian market,” said GSK Canada in a July 23, 2014 statement. “We had no objection to the proposed amendment.”
GSK further said in its statement. “In the letter, the agency [Health Canada] raised issues related to certain quality control and manufacturing procedures at the facility. We are making progress addressing these concerns, and we are committed to working with the agency to fully resolve all outstanding issues. Patient safety is our first priority and we are confident in the safety of the influenza vaccines we have provided to patients. Every batch of GSK vaccines is subject to extensive review before it is released. Vaccines that do not pass this rigorous review are discarded.”
GSK produces influenza vaccines for the US and Canada at the Sainte-Foy facility. Pending FDA approvals, GSK anticipates providing between 28 million and 33 million doses of influenza vaccine to the US for the 2014-2015 flu season. GSK is also working with Canadian health authorities to meet GSK supply commitments for 2014-2015.
“While we work with the FDA to fully address its concerns, we also are providing regular updates on our progress to the US Centers for Disease Control and Prevention (CDC), the Public Health Agency of Canada (PHAC) and Health Canada to support their efforts in managing supply of influenza vaccines for the 2014-15 flu season,” said GSK.
Source: Health Canada and GSK Statement