Guidelines for quality agreement in pharmaceutical contract manufacturing

Abstract

For the purposes of this guideline, the following terms have the meanings hereby assigned to them. They may have different meanings in other contexts. Bulk Product means any medicine that has undergone all processing stages up to, and produced in large quantities, but excluding, primary, secondary, and tertiary packaging. Contract Giver means a legal entity who has legal ownership of the finished product or manufacturing facility or market authorization holder of products who will be applying to the EFDA for manufacturing of its product to be carried out by another manufacturer (contract acceptor) on its behalf.