Zdrowie i gospodarka · 01/08/2000

FDA Releases Draft Guidance on Good Manufacturing Practice for Active Pharmaceutical Ingredients

The Food and Drug Administration (FDA) has released a draft guidance document titled 'Q7A ICH Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients,' which outlines current good manufacturing practice (CGMP) for the production of active pharmaceutical ingredients (APIs). This document was developed under the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).