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When the United States Food and Drug Administration (FDA) called…
When the United States Food and Drug Administration (FDA) called for a shakeup of pharmaceutical production in 2002 it recommended the early adoption of technological advances and the application of modern quality management techniques. It believed that this would make manufacturing processes more robust and improve product quality.1
In this In-Depth Focus: Quality control of freeze-dried oral formulations;…
In this In-Depth Focus: Quality control of freeze-dried oral formulations; Regulatory and quality assurance challenges in continuous manufacturing...
During 2002, the United States Food and Drug Administration (FDA)…
During 2002, the United States Food and Drug Administration (FDA) requested rationalisation and modernisation of the manufacturing base for pharmaceutical production. This was in the hope that modernising the supply chain would enhance the robustness of manufacturing processes, thereby reducing product failures and, importantly, significantly enhancing product quality.1 The FDA’s…
