Regulatory Focus™ > News Articles > To Boost Transparency, Canada Launches GMP Inspection Database

To Boost Transparency, Canada Launches GMP Inspection Database

Posted 15 April 2015 | By Michael Mezher 

To Boost Transparency, Canada Launches GMP Inspection Database

Canada's Health Minister Rona Ambrose announced the launch of a new publicly accessible database for manufacturing inspections on 13 April 2015.

The new Drug and Health Product Inspection Database will allow Canadians to search for timely information on good manufacturing practice (GMP) inspections conducted by Health Canada.

Background

The database is part of a larger effort by Health Canada to improve transparency after being called out publicly by The Toronto Star last year for its opaque handling of GMP inspection results.

Through its investigation, The Toronto Star found that some companies that had been cited for GMP violations by the US Food and Drug Administration (FDA) were still allowed to sell their products in Canada. Some of the violations include data manipulation, early product deterioration and failure to report adverse effects. At the time, The Toronto Star criticized the regulator, saying "Health Canada does not give any details of the problems, if any, that it finds during individual inspections [and] does not even make public the names of the 20-plus companies that have been cited since 2012 for severe manufacturing violations."

In response, Health Canada published a list of the inspections it carried out between 2012 and 2014. In March 2015, Health Canada announced it would "increase the frequency of planned and unplanned inspections" of drug establishments, and reminded Drug Establishment License (DEL) holders of their responsibility to comply with current GMP guidelines. At the time, Health Canada posted a new inspection tracker tool to its website, which listed manufacturers that have been flagged for GMP issues and said it would begin posting the summary reports from inspections on 1 April 2015.

The New Database

The press release states that the new database will contain information on the inspections the regulator conducted since 2012. Health Canada says it will still update the inspection tracker it launched in March to keep tabs on "emerging issues."

The Drug and Health Product Inspection Database is designed for use by the general public and features "plain language [and] timely information on inspections." Users can search the database by establishment name, reference number, location, inspection dates and compliance rating.

Once a search has been initiated, users can select the establishment they wish to view for details about the establishment, including the number of times the site has been inspected in the past three years. From there they can select the establishment's rating to see a summary of the inspection, including the observations cited in the inspection report.

Press Release, Database


Categories: Regulatory News

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