In Focus: GxPs
Posted 01 July 2008 | By
Regulatory personnel need to know what constitute "good practices" and, moreover, what constitute "current" good practices. As we deal with regulatory agencies such as FDA, we meet and agree upon a course of action. This course may include manufacturing considerations or a clinical development plan. When we complete the work and submit it to FDA, the agency often adds to the activity or disagrees with what has been done. When asked why it wants to change what had been agreed, FDA says things have "evolved." This non-Darwinian evolution is the state of the art at a given time, or "current" good practices.