Health Canada Regulations Amending their Good Manufacturing Practices to include APIs

Health Canada revised and published the final GMP regulations to include Active Pharmaceutical Ingredients (APIs).  This revision represents an effort to ensure adequate control over the pharmaceutical supply chain, from API to finished drug product.

Health Canada undertook this effort to align with other “industrialized countries” with incorporation of API requirements into their GMPs.  The effective date (November 2013) for the GMP requirements for API is 6 months after its publication.  Companies have until February 2014 to submit an establishment license application, and still be considered in compliance.  Many of the requirements seem to align with ICHQ7, GMPs for Drug Substance, though specific labeling requirements are being implemented to allow tracking of APIs from the actual manufacturer to the manufacturer of the dosage form. Health Canada indicates that incorporating API requirements will allow work-sharing of inspection responsibilities with those countries with which it has a Mutual Recognition Agreement (MRA).

Read the regulations here.