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Site Licensing

The NHPD issues site license for 4 types of activities. They are manufacturing, labeling, packaging and importing. Licenses are only issued for these activities in Canada. Having a site license indicates that the site is following Good Manufacturing Practices (GMP). Following procedures (as outlined in standard operating procedures) and proper documentation attests to following GMP. In preparing a product license application we can also prepare the standard operating procedures and applicable forms in order to ensure you are in compliance with the site license regulations and GMP.

For an importing license a minimum of one foreign site (a manufacturing facility outside of Canada) must be added to the site license application. Other things to keep in mind is that a Quality Assurance designate must be handling various functions of the site license. This QA designate can be in-house or a third-party, such as Quality Smart Solutions to manage these activities.

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