USP 797 design and cGMP (Current Good Manufacturing practices) Guidances
This is one of many you can seek out.If you go to the USP website it appears as though you have to purchase the guidlines but this is a run down of it from 1 link that I researched.Suffice to say that training of individuals will be key and I expect they will have to hire in several individuals who are already USP 797 compliant or experienced and have passed the rigorous testing requirements.
However,since they are in Canada I expect even so it does cross country lines and if compliant in Canada,will also be complaint in the USA or vice/versa.
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