Just about a year ago, in July 2011, FDA published a roadmap for addressing the challenges of globalization. The roadmap, “Pathway to Global Product Safety and Quality,” was based on four core building blocks: with a global coalition of regulators, build and strengthen the product safety net around the world; develop a global data-information system; expand intelligence gathering and use, focused on risk analytics and modernized IT; leverage and prioritize resources based on risk.
In the years ahead, the worldwide industry should expect to see: improved consistency among regulatory inspections; inspections that are well-informed by global issues affecting product quality, safety, or efficacy; enhanced recognition and reliance upon the regulatory inspections conducted by recognized health authorities, which may reduce the total number of regulatory inspections at any one site but also increase the impact of each inspection.
Regardless of which health authority conducts the inspection, the preparation for, and management of, the inspection process is quite similar. Whether it’s a surveillance, pre-approval, or for-cause inspection, regulatory inspections are crucial activities that affect business success on several levels. David Elder at PAREXEL Consulting, a former FDA official, advocates a few key steps to prepare for and manage an inspection. Read his tips here in the July issue of PharmTech.
The above excerpt is written by David Elder.