Canada Extends GMPs to All Drug APIs

The same GMPs that finished-dose pharmaceutical companies in Canada are required to follow will soon apply to all active pharmaceutical ingredients (API) used in the country. The supply-chain-tightening move sets forth new mandates on licensing, recordkeeping and API tracking.

Under amendments to the Food and Drugs Act, effective Nov. 8, 2013, drugmakers will be required to use only GMP-compliant APIs in finished drugs. Distributors or importers will be prohibited from selling finished drugs unless those products and their APIs are GMP-compliant.

The regulations also extend establishment licensing requirements to all API manufacturers, packagers, labelers, testers and importers. An establishment license will not be issued until the applicant has been assessed by Health Canada and found to be in compliance with GMP rules.

And all API manufacturers, packagers, labelers, distributors, wholesalers and importers will also have to meet strict labeling requirements for any container label or document accompanying the drug.

If applicable, all parties in the supply chain will also be required to list:

• Whether it is the manufacturer, packager, labeler, distributor, wholesaler or importer;
• The date of the applicable activity;
• The expiration or re-test date of the drug; and
• The lot number.

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