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Stephen Tindal

 

Modernising the supply chain using continuous manufacturing

When the United States Food and Drug Administration (FDA) called…

15 November 2017 | By , ,

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

QA/QC In-Depth Focus

In this In-Depth Focus: Quality control of freeze-dried oral formulations;…

25 August 2017 | By

In this In-Depth Focus: Quality control of freeze-dried oral formulations; Regulatory and quality assurance challenges in continuous manufacturing...

Continuous manufacturing: regulatory and quality assurance challenges

During 2002, the United States Food and Drug Administration (FDA)…

22 August 2017 | By , ,

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…

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