Per in-Pharma Technologist.com, Regulation Health Canada first publicly introduced the idea of extending good manufacturing practice laws to active pharmaceutical ingredients in the September 2012 publication of the Canada Gazette. It was only this past week that Canada began requesting industry feedback on the issue.
Currently in Canada, GMP laws are only a factor in high risk ingredients, “standard API’s are not covered by GMP and instead their quality is assessed through testing before they are used” shares in-Pharma editor. Health Canada is clearly exploring extending the GMP requirements so they apply to all API’s and extend the drug establishment licensing requirements.
For help with your GMP quality system or with API supplier audits, contact us at contact@pearlpathways.com