carrying out the final release of the final product, associated with at least one production step, except the design, distribution, sterilization, packaging and labeling steps. In this case, the packaging activity considered as a sterile barrier system for products declared as sterile and the manufacturing units of medical devices for In Vitro diagnostics that perform the steps of impregnation, lamination or cutting of immunochromatography strips are also subject to certification of good manufacturing practices.