Zdrowie i gospodarka · 17/04/1998

Draft Guidance for Industry on Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients.'' This draft guidance is intended to provide guidance on current good manufacturing practices (CGMP's) for manufacturing, processing, packing, or holding active pharmaceutical ingredients (API's). The draft guidance is intended to help ensure the quality and suitability of API's for use in the manufacture of drug products.