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Zdrowie i gospodarka · 24.09.2001

Current Good Manufacturing Practice for Active Pharmaceutical Ingredients; Public Workshops

The Food and Drug Administration (FDA) is announcing a series of workshops to discuss the application of the International Conference on Harmonisation (ICH) guidance for industry entitled "Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients," which will be announced in a future issue of the Federal Register. The workshops, which will be held in collaboration with the Parenteral Drug Association, the Pharmaceutical Research and Manufacturers of America, and the Generic Pharmaceutical Association, are intended to provide a regulatory perspective on current good manufacturing practices (CGMPs) for active pharmaceutical ingredients (APIs). The workshops are being scheduled to help ensure that all APIs meet the standards for quality and purity they purport or are represented to possess.

Source: Federal Register — Food and Drug AdministrationOpen original release →