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A Call for GLP in Drug Discovery

GLP and GMP are inevitably linked to the pharmaceutical industry. Well, not to the complete industry. The exception is the discovery part of the business, balking at the very idea of GLP in research and painting dark pictures of pointless regulations smothering creativity.

True, the GxPs do not apply. Nevertheless, the significance of quality is hardly debatable which raises an important question: If the GxPs do not define the quality requirements of drug discovery, WHO DOES?

QUALITY DEFINITIONS 

The exclusion approach – “GxPs do not apply to drug discovery” – is of course some kind of definition but obviously a bit limited in terms of what should be done. Even worse, it is easily interpreted as “rules do not apply at all”. This is a dangerous attitude, since no rules and no commitment quickly lead to quality anarchy.

Relevance of quality accepted, ... read more!