January 8, 2013
Canadian public health officials have announced the expansion of Health Canada's regulatory authority to inspect and require all active ingredients (AIs)-sometimes referred to as active pharmaceutical ingredients (APIs)-to meet current good manufacturing practice (CGMP) standards.
The new requirements will require all AIs used in pharmaceutical products sold in Canada to have met CGMP standards regardless of where they were produced-either in Canada or internationally.
Many facilities now manufacture just AIs or APIs, sending the finished product to a second manufacturing facility that then turns the ingredients into a finished product. Compounding this trend, these AI/API manufacturers are increasingly moving abroad, making it more difficult for regulators to track and inspect a drug's entire supply chain from start to finish.