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through an integrated systems approach, to product quality regulation, focused on sound science and engineering principles for assessing and mitigating risk of poor product and process quality within the context of the intended use of pharmaceutical products.  And with that sort of a framework, I think what is the desired state for pharmaceutical manufacturing from development and manufacturing?

One, product quality and performance achieved and assured by design of effective and efficient manufacturing processes.  The emphasis there on design is to sort of emphasize that testing to document quality is not a paradigm which really is the current state of thinking.  It has to be by design.

Product specifications, based on a mechanistic understanding of how formulation and process factors impact product performance, continuous real-time assurance of quality, regulatory policies tailored to recognize the level of scientific knowledge supporting product applications, process validation and process capability, risk-based regulatory scrutiny that relates to, one, level of scientific understanding of how formulation and

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