Testing of raw materials (RM) is a responsibility of the fabricator. Therefore, an observation will be
made to a fabricator for not testing a particular RM (even when this RM is provided by the client) if he is not
excluded by his client according to a contract. Interpretation 3.2 under Section C.02.012 Manufacturing
Control covers the written agreements with regard to the fabrication, and packaging/labelling among the
parties involved, and Interpretation 6.10 under Section C.02.015 Quality Control Department covers the
written agreements with regard to the testing among the parties involved. If no such agreement is in place, the
observation will be made against the party responsible according to the Good Manufacturing Practices.
