Taming the Regulatory Beast: Regulation versus Functionalism

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: “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.”

There are two schools of thought that conflict over what constitutes effective regulatory compliance. One abides by the methods FDA favoured for many years. The other prefers a retrenched view, one more closely informed by the original objective of ensuring good scientific practice. The debate’s highly technical and quasilegalistic substance can prove challenging to follow sometimes.

 A Brief History of GLPs and cGMPS In 1975, the US Food and Drug Administration (FDA) faced an apparent failure of good science when it identified serious flaws in a non-clinical toxicological safety study.1 The study had been submitted in support of applications to market new drugs and food additives. These were among the problems FDA cited:

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