Baseball season ended over a month ago, and I am already looking forward to when teams report for spring training. At this time, team management is evaluating where the team succeeded and where improvement is needed. It is interesting that the ICH Q10 Pharmaceutical Quality System guidance recommends pharmaceutical management take the same approach towards quality objectives.
Just look around, watch the television, read the newspaper, and what do you see? Seems like very few reasons to be thankful. School and workplace shootings, the political scene is as nasty as I ever remember in my 70 years on earth. Climate change is threatening the future of our children, and the environmental controls have been set back 50 years as the oceans continue to rise,
Like death and taxes, eventually every pharmaceutical testing laboratory will get a regulatory agency inspection. The anticipation of a regulatory inspection will instill great angst even within the most compliant laboratories. The anticipated inspection might be a periodic inspection, but most often is a Pre-Approval Inspection (PAI). The anxiety about an impending inspection often triggers a request for an independent third-party audit of the facility including the laboratory.