The US parent company cannot be considered the vendor. To be certified, the vendor must be the
original source of the API. In this instance, the US company would be acting as a contract laboratory and
should meet the requirements under Interpretation 6.10, Section C.02.015 Quality Control Department. When
received by the Canadian site, a specific identity test must be performed and if for an API, the testing must be
as per Interpretation 6.1, Section C.02.009 Raw Material Testing (i.e., each container sampled and tested).
The above mentioned would be acceptable based on the fact that no repackaging is done by the US site (i.e.,
the materials must be supplied in their original containers with the original labels and Certificate of Analysis
(C of A) as received from the vendor).
