Canada tightens GMP rules for active ingredients
pharmafile | May 21, 2013 | News story | Manufacturing and Production | API, Canada, GMP
Canada’s Food and Drug Regulations have been amended to extend the requirements for Good Manufacturing Practices (GMP) to active pharmaceutical ingredients (APIs) used in medicines.
The amendments – announced by Canada’s health minister Leona Aglukkaq – will come into force in the third quarter of this year.
They effectively make compliance with the International Conference on Harmonisation’s (ICH) Q7 Guidance on GMP mandatory, which was finalised in 2000 but has to date been only been a voluntary requirement in Canada.
The new rules would mean that: “The current high standards of drug safety in Canada are getting even stronger,” said Aglukkaq.
The notice of the changes in the Canada Gazette says that there has been growing concern over the quality of API around the world, “particularly as the manufacturing of API and dosage-form drugs has been increasingly outsourced to developing countries”.
Among other things, ICH Q7 compliance introduces a new record-keeping requirement that will help trace active ingredients through the supply chain “from their place of origin to the manufacturers that put them into products for consumers”, she added.
ICH Q7 covers all aspects of GMP – including quality management, personnel, building and equipment practices, record-keeping, materials management, storage and distribution, laboratory testing and validation of processes. The requirements will extend Canada’s drug establishment licensing (EL) requirements to apply to all API manufacturers, packagers, labellers and importers.
“Our government is committed to protecting the health and safety of Canadians and their families,” said Aglukkaq, adding: “That is why we are taking action to improve the safety of Canada’s pharmaceutical drug supply.”
Health Canada said it has begun working with Canadian companies to help them better understand their new responsibilities in manufacturing drugs. The amended regulations become mandatory on 8 November.
Phil Taylor
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