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A Closer Look: Supplement GMPs May Offer Insights For Drug GMPs

Executive Summary

FDA's approach to good manufacturing practices has been moving toward a focus on testing input materials and manufacturing processes rather than solely on testing end products - an evolution reflected most recently in the Center for Food Safety and Applied Nutrition's new rules on dietary supplement GMPs

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In the coming months, new pre-approval inspection compliance guidelines will be implemented at CDER. For the most part, the undertaking is designed to refine the categories that would prompt a pre-approval investigation request and make them more "risk-based," in keeping with FDA's cGMPs for the 21st Century Initiative (1"The Pink Sheet," Aug. 27, 2007, p. 27). The revisions also are supposed to clarify the role of the various offices in the process...

FDA changing pre-approval inspection guidelines

In the coming months, new pre-approval inspection compliance guidelines will be implemented at CDER. For the most part, the undertaking is designed to refine the categories that would prompt a pre-approval investigation request and make them more "risk-based," in keeping with FDA's cGMPs for the 21st Century Initiative (1"The Pink Sheet," Aug. 27, 2007, p. 27). The revisions also are supposed to clarify the role of the various offices in the process...

Good Manufacturing Practices: FDA’s 21st Century Quality Initiative Turns From Concept To Implementation

The pharmaceutical industry is welcoming FDA's move toward greater flexibility in quality control inspections and manufacturing changes for firms with good quality systems but seeks more concrete information on how flexibility will be achieved in practice

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