Taming the Regulatory Beast: Regulation versus Functionalism

From: Pharmaceutical Technology Europe | Date: March 1, 2005| Author: Corbin, Virginia L; Balogh, Michael P | Copyright information

Mass spectrometrists working in pharmaceutical development tend to approach the issue of regulatory compliance with some trepidation. We know we can't escape its considerable demands for our time and attention, and we're willing to act accordingly to ensure that our instruments and procedures comply. Yet it often appears that requirements are expanding in both scope and detail. This month's co-author succinctly sums up the issue: "FDA wants to see quality built into the product at the beginni...

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