Zdrowie i gospodarka · 04/10/2004

Draft Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations." The draft guidance describes the key elements of a robust quality systems model and shows how persons implementing such a model can achieve compliance with the CGMP regulations.