Zdrowie i gospodarka · 5.09.2003
Draft Guidance for Industry on “Sterile Drug Products Produced by Aseptic Processing”
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Sterile Drug Products Produced by Aseptic Processing." FDA expects that enhanced compliance in the area of sterile drug manufacture will lead to a higher assurance of process consistency and minimize supply problems with therapeutically necessary drugs.