GMP-ACE.COM

As a former FDA Inspector, Calvin Koerner found FDA's training and compliance evaluation tools to be lacking. There was little standardization for how inspections were completed. Inspection coverage and outcome was often dependant on the inspectors performing the inspection. Every inspector in the division had their own unique method for conducting inspections. Seldom were these individual methods written down or comprehensive... Using the FDA's methodology, he found himself struggling to be consistent and comprehensive. He concluded a written standard was needed to ensure compliance evaluations were completed consistently and effectively. His first attempt at developing such a standard was created on paper. The approach was to ensure all six quality systems were covered during any given inspection, instead of the two to four systems stipulated by FDA procedures.