Health Canada launches risk-based inspection classification system

The regulator says the old system, by which site inspectors could issue only a compliant or non-compliant rating, was too ambiguous and left too much room for confusion.

The new guidance​, launched on Tuesday, means the organisation will consider the risk involved along with the “nature and extent of the deviation in relation with the category of products evaluated”​ before handing out a classification on a numerical scale; one being the highest risk, three the lowest.

In a statement, Health Canada said it hopes the move will make rating more uniform, as well as raising industry awareness of what is “unacceptable”​ in terms of compliance.

“​​Attribution of a non-compliant (NC) rating may have serious consequences for a company, ranging from the implementation of important corrective measures to the temporary suspension or termination of the Establishment Licence (EL),”​ Health Canada explained in its draft. “Therefore, these situations of non-conformity have to be well defined, unambiguous and directly supported by the applicable regulations.”​

However, despite recognising the different shades of grey in drug manufacturing inspection, the authority still say some offences will always lead directly to the worst classification.

“Most of the situations involving fraud, misrepresentation or falsification of products or data will generate a NC rating, irrespective of the category of products involved,”​ the organisation said.

Overseas safety​

The news follows University of Victoria’s drug policy researcher Alan Cassels’ call for stricter inspection of the overseas drug manufacturing facilities that provide medicine to Canada.

Writing in the Canadian Medical Association Journal (CMAJ) earlier this week, he said that inspectors should take note from the US Food and Drug Administration and travel to plants in other countries; especially those in emerging markets where compliance has been an issue.

"How often do our regulators dust off their passports and fly to China or India to ensure that the plants producing pharmaceuticals are clean, follow proper manufacturing techniques and contain what is on the label?”​ he wrote.

He also warned that the regulatory body should change the fact three-quarters of medical imports come from countries which do not have any manufacturing standards agreements with Canada.

However in an interview with CBC News, Stephanie Reid, a manager at Health Canada’s drug inspection unit, said the concerns were unfounded because drug imports are inspected upon arrival.

"Canadians can be assured that before any product comes into the country, there's always an inspection,”​ she said.