Taming the Regulatory Beast: Regulation vs. Functionalism

Mass spectrometrists working in pharmaceuticals 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 coauthor succinctly sums up the issue: “The FDA wants to see quality built into the product at the beginning of the development cycle because quality cannot be ascertained at the end.

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