Inspection Readiness – A Marathon, Not A Sprint
May 10, 2017
In order to respond successfully during an FDA, EMA, MHRA, PMDA or other health authority inspection, a program of continuous inspection readiness is required. One-off sprints to prepare are not very likely to be sufficient, even for very experienced personnel.
An effective inspection readiness program is a sustained effort spearheaded by a broad-based team composed of both key resources in the business as well as QA. It is the business that supplies the expertise to set standards and assess gaps requiring remediation while QA supplies the expertise related to inspection management and ensures the business is aware of the most current expectations of the regulators and also supplies specific inspection readiness training.
It is important to remember that this team spearheads the program. Inspection readiness is really only ever achieved when all personnel involved throughout trial activities, including vendors and BPOs, are actively engaged throughout every clinical trial project.
Know your vulnerabilities. Identify them candidly and address them. It is widely known in industry (and, of course, among inspectors) that the leading vulnerabilities across the board are change control and training documentation. But a successful inspection readiness program hardly stops there. Targeted inspection readiness training and ongoing reinforcing messages need to be effected on a sustained basis, as should be careful periodic quality reviews of documentation and process adherence. All existing CAPAs must be actively tracked to timely completion. The identified inspection readiness team coordinates, schedules, advises, provides for training, and monitors the required readiness activities carried on throughout the organization.
No one can guarantee an inspection will result in no findings or no FDA 483 being issued, but a well planned, well executed and sustained and vigilant inspection readiness program permeating the organization is the best way to maximize the probability of success. If you haven’t started yet, today is not too soon. The day an inspection is announced is clearly far too late.