Starting materials that are manufactured at site with:
EUGMP certification inspected by an EU member state
A state with a recognised GMP standard by a non EU competent authority such as Iceland, Liechtenstein, Norway, Australia, Brazil, Israel, Japan, Switzerland and the USA.
A Written Confirmation declaring that the site has equivalence to EUGMP.
The material will be named on the GMP validation document. These materials will also have a DMF/ ASMF.
