Zdrowie i gospodarka · 01/08/2000

International Conference on Harmonisation; Draft Guidance on Good Manufacturing Practice for Active Pharmaceutical Ingredients; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "Q7A ICH Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients." The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The document is intended to provide guidance regarding current good manufacturing practice (CGMP) for manufacturing of active pharmaceutical ingredients (API's). The recommendations in the draft guidance are intended to assist in the manufacture of API's that meet the standards for quality and purity they purport or are represented to possess.