Regulatory Mythbusters – Sorting Fact From Fiction

By David Churchward, Ron Ogilvie, and Bryan Wright

The authors tell us that there are GMP-related “myths” created and propagated through industry. These myths may be created for a variety of reasons – regulatory changes, perceived regulatory inconsistencies, and regulatory misinterpretation. In this article, several myths are “busted” and better communication with regulators is recommended to help prevent future myths from rising.

Anthropologists tell us that people in all societies – past and present – create myths. Myths are often created and perpetuated because there is no apparent rational explanation or identifiable cause for the misfortunes that befall us. Thus, in the prescientific, tribal world, random and unexplained misfortunes, such as a poor harvest, an unexplained death, flood and famine, are often explained through myth-making.