Health Canada has recently taken actions to improve the transparency of their GMP inspection activities. Both industry and the general public appreciate all efforts toward transparency in government actions. The efforts described below are part of the Open Government Initiative that began in 2011 and address transparency in Health Canada GMP inspections of pharmaceutical firms. The data below were made available in 1-Q-2015 and cover the time period beginning in 2012. First a disclaimer, I focus on GMP Regulatory Intelligence so my conclusions and opinions come from that perspective and may differ from those who might use these data for different purposes. After spending some time working thru the various collections of information posted by Health Canada, here are my conclusions / thoughts:
- OVERALL CONCLUSION: Information provided here will benefit the general public and firms that may be evaluating potential suppliers or business partners. The evaluation of potential suppliers or business partners, including contract manufacturers / laboratories, will require additional information but these data provide a high level description of potential concerns that should be addressed in due diligence evaluations. The information may be of limited utility, however, for firms that want to learn from problems encountered by others during inspections by Health Canada. Observation summaries often state that “deficiencies” exist in specific areas without identifying the specific process or action that resulted in that conclusion.
- The inspection tracker currently lists 17 firms for whom Health Canada is performing an evaluation of potential risks posed by the inspection outcomes. The tracker “addresses emerging issues identified through our drug inspection program” identifying the specific firm in question and it’s address, the status of the issue, the source of information and the reason(s) for taking action. It includes links to specific product recall information when these actions were taken. Sixteen of the seventeen sites are located outside of Canada, including India (12), China (2), Italy (1) and Thailand (1). Health Canada performed inspections for 2 of these 17, issues for the others were brought to their attention by a “regulatory partner” or a Canadian Importer. The sites outside of Canada appear to be ones that have been the subject of FDA actions (warning letters or import alerts) or EMA actions (Eudra GMDP reports of non-compliance) based on the sites identified. The specific practices that resulted in this evaluation are summarized briefly as either “General GMP Observations” or “Data Integrity” without additional detail.
- The Health Canada Drug and Health Product Inspection Page includes links to three collections of information:
- Results of Drug Inspections Conducted in Canada. This includes 1,329 entries. Many of these are importers, packagers and distributors. This collection identifies, for example, the start date for the inspections, identifies those inspections that are currently in progress (something other authorities do not do routinely), the establishment name, and inspection outcome (compliant or non-compliant). The inspection history of the site within the last three years is available if you click on the name of the firm. For those sites deemed “compliant”, details of observations made during the inspection are not provided. For those deemed “non-compliant” please see the next bullet point.
- The database of Non-compliant drug inspections in Canada provides the 3-year inspection history of the firm if you click on the name of the firm, the start date of the inspection, the Health Canada GMP regulations that were violated and a brief summary of observations associated with that regulation. It currently includes 54 entries, which represents 4% of the total inspections conducted in Canada since 2012. The brief summary does not have the level of detail that would be found in a form FDA-483 or warning letter, but does provide useful information, and is easy to navigate. It often begins “Deficiencies were noted” in a specific procedure or practice, but the nature and details of why the procedure or practice were deemed deficient are not provided. This limits the ability of other firms to learn from the inspection results. The search capability (“filter items”) does not permit a search of all non-compliant reports for a specific topic such as “sterility”, “OOS” or “documentation”. It does however permit a search when a specific report is opened. The reader can then select for words or terms that are found in either the regulations column or in the observation summary column. This is useful information but is one step removed from the actual observation which would provide more detailed information. It would also be useful to be able to limit the search to the observation summary and not automatically include the terms in the cited regulation column.
- The database of Foreign Site Inspection Search Results includes 2,520 entries. Sixteen of these inspection results, 1% of the total, have been classified as non-compliant. Unlike the data collection of sites in Canada that were deemed to have non-compliant inspection outcomes, a summary of the observations from these inspections is not provided. Hopefully, this is a work in progress and information will be added in the future. And since these summaries are not published, there is no way to search for specific words or terms.
In summary, the transparency by Health Canada in identifying GMP inspections conducted, and their outcomes, is a welcome effort. The lack of specificity in the data presented may limit how other firms might use this information to improve practices and procedures at their site in order to prevent similar inspection problems.
2015 Copyright, Unger Consulting Inc. This item also appears in a subscription based GMP Regulatory Intelligence Newsletter published by FDAzilla.