Since the early 1990s, the Food and Drug Administration (FDA) has focused attention on Good Manufacturing Practice (GMP) compliance within the active pharmaceutical ingredients (API) industry. Over the years, as well as recently, this industry has striven to play catch-up and comply. This paper discusses both general and specific API industry trends associated with this increased compliance effort.
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Angelucci, L.A. Current Good Manufacturing Practice Design Trends in Active Pharmaceutical Ingredients Facilities. Ther Innov Regul Sci 33, 739–746 (1999). https://doi.org/10.1177/009286159903300312