Canada makes global GMP mandatory for APIs
Rules will apply to all API manufacturers, packagers, labellers and importers for human pharmaceuticals
The Canadia government has announced that from 8 November 2013, pharma manufacturers within Canada will have to abide by global good manufacturing practice (GMP) standards for their active ingredient production.
Based on the International Conference on Harmonisation’s (ICH) Q7 Guidance, which has thus far been voluntary within Canada, the new rules would, claimed Canadian health minister Leona Aglukkaq, mean that ‘the current high standards of drug safety in Canada are getting even stronger’.
She noted: ‘Among other things, they create a new record-keeping requirement that will help us trace active ingredients through the system, from their place of origin to the manufacturers that put them into products for consumers.’
The rules will apply to all active ingredient manufacturers, packagers, labellers and importers for human pharmaceuticals only. The federal ministry Health Canada said that it had begun working with Canadian companies to explain the new responsibilities and would be making guidance available online.