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These guidelines interpret the requirements for good manufacturing practices (gmp) in part c, division 2 of the regulations Guidance documents like this one are meant to help industry and health care professionals understand. They were developed by health canada in consultation with stakeholders.
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Purpose this guide is for people who work with active pharmaceutical ingredients (apis) and their intermediates to understand and comply with part c, division 2 of the food and drug regulations (the regulations), which is about good manufacturing practices (gmp) They were developed by health canada in consultation with stakeholders You can find definitions to terms used in this guide under appendix a
This guide applies to the following.
Before you fly to canada, whether you are a resident or a visitor, the airline will check your identification and travel documents However, boarding the plane does not guarantee that you can enter canada When you arrive, a border services officer will check your identity and citizenship to determine if you're admissible This guide provides you with an overview of the commercial importing process for businesses importing goods into canada
It is intended to complement and not replace existing regulations, acts and references detailed in memoranda series d1 to d22. Health canada has been working with international partners towards the inclusion of active pharmaceutical ingredients in our mras What period of gmp compliance validity will health canada assign to foreign buildings where the fabrication, packaging/labelling and testing of active ingredients occurs based on the attestation form?
