5 Steps to Surviving a Regulatory Inspection

5 Steps to Surviving a Regulatory Inspection

Much of my team’s day-to-day responsibilities come down to planning: planning for good quality assurance practices, planning in case of a regulatory inspection, planning responses to questions during an inspection, and even planning for future inspections in the midst of an ongoing one.

Based on a recent Food and Drug Administration (FDA) inspection at UBC headquarters that returned no observations, this planning has been time well spent. In fact, no findings1 have been returned in the nearly 40 regulatory authority inspections that the UBC QA team has managed or onsite inspections of manufacturer-sponsored programs that UBC managed.

These steps are the backbone of the UBC’s Quality Assurance program and the reason we’ve successfully completed so many inspections.

  1. Create a quality management system that meets regulatory guidelines
    The FDA, Medicines and Healthcare Products Regulatory Agency (MHRA) and European Medicines Agency (EMA) have numerous guidelines for clinical research and drug safety programs. UBC has developed and implemented a quality management program that meets the global regulatory requirements 
  2. Conduct proactive internal audits to confirm compliance
    Institutionalizing the standard operating procedures outlined in the quality program starts with rigorously training all staff members. It continues with proactive internal audits to ensure compliance with the SOPs as well as applicable regulations. The results of the internal audits can identify process improvement initiatives that require changes to the procedures and ensure QA SOPs remain top-of-mind for all team members.
  3. Implement a procedure for managing regulatory inspections
    When a regulatory inspector arrives for an inspection, it’s important to have a process outlined. This includes instructions for the receptionist on how to greet the regulatory official, which senior staff members should be notified, and what physical accommodations should be made, such as providing a phone and workspace for the inspector. This allows the inspection to commence promptly and in an orderly fashion.
  4. Document the inspection process
    This step is crucial for being prepared for future inspections. It is important to build a database of information requested during an inspection. That includes questions and answers as well as documentation reviewed.  The database allows UBC to trend the areas and documents that are inspected in order to proactively ensure that best practices are implemented and to assist UBC with manufacturer discussions regarding program design and implementation.
  5. Let past experience guide responses
    The best offense is a good defense. In this case, it means consulting past inspections to anticipate questions that will be asked and documents that may be required. Expeditiously providing information to the inspection can speed the process along.

Manufacturers need a service provider that intimately understands the regulatory landscape and institutes practices that keep programs compliant. That is why UBC is a trusted partner – before, after, and during an inspection – for so many pharmaceutical and biotech companies. Planning for a regulatory inspection starts now. Contact me to discuss how the UBC QA team can be on your side the next time the FDA or MHRA arrive at your office.

1”No findings” relates to UBC responsibilities as related to the program that was inspected as per the feedback provided to UBC.