Health Canada recently issued a summary report of their recent audit of ID Biomedical (GSK). Within this report, they presented summaries of both their 2012 and 2014 Inspections. Enclosed are copies of selected sections of both Inspections as well as my additional comments.
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.”
While it is difficult to determine the exact Observations from what was stated in the summary, the comment regarding “to restrict the growth of microorganisms in the environment, prevent contamination and ensure sterility” are some of the same items noted within the 2014 FDA Warning Letter. These comments made by Health Canada would raise the interest level of FDA Investigators.
“JUNE 2014 INSPECTION:
…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.”
Please note that a similar comment was made within the recent FDA Warning Letter. Also, any time that sequential Form FDA 483s occur, and that the Observation is recurring, this recurrence is likely to cause the issuance of a Warning Letter. Health Canada acknowledged a repetition of similar Observations during both 2012 and 2014, but did not increase the severity of the Citations beyond a “Major”. Often when Regulatory organizations find several “Major” Citations, they will elevate the combination of Citations to a “Critical”.
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.”
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”. This particular observation could be significant since the issue of lack of sterility would potentially cause the manufacture of non-sterile product. The comparison of “the rejection rate between the actual product line and the simulation” is difficult to discern as to its meaning. It appears that this does not relate to sterility, but to all of the vials that may have been removed for a variety of AQL reasons.
“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…”