Tony Bumarch
VP Global Quality Assurance

March 16, 2021

In Part 2 of our blog series, we discussed the following three steps to take towards being inspection ready: developing an FDA GCP Inspection Readiness Plan, performing an independent audit of the Trial Master File, and creating and annotating a BIMO Compliance Checklist. In Part 3 of our series, we would like to discuss three additional tips sponsors should consider in order to optimize FDA GCP inspection outcomes. The importance of these additional steps increases if there are any concerns following a TMF audit and annotation of a BIMO Compliance Checklist as described in tips 2 and 3 in the previous post.

Tip 4: Provide Study Team Training for the Actual FDA Inspection

The designated inspection manager or host should provide training for all key roles needed during the FDA inspection. Training should include an overview of necessary logistical arrangements for the inspection as well as presenting clear expectations for each role involved in hosting the inspection, responding to the inspector’s requests, or providing support services for the provision of requested documentation. Establish a goal of responding satisfactorily to all of the FDA inspector’s requests before the inspector leaves the site. This requires efficient organization of informational resources and assignment and training of staff to function in all key roles, including the host, QA support, subject matter experts, scribes and runners.

The training should also address any shortcomings identified during the mock inspection, whether in the performance of any individuals involved or the processes and resources required to address the inspector’s requests in a timely, effective manner. Depending on experiences during a mock FDA inspection, inspection preparations may benefit from an additional pre-inspection run-through to ensure that any issues have been resolved.

Tip 5: Conduct an Independent Mock FDA GCP Inspection

An independent mock FDA GCP inspection will be most productive following preparations based on the annotated BIMO Compliance Checklist for your program. Such a mock inspection should include testing logistical arrangements for hosting an FDA inspector. For example, the mock inspection should involve setting up an Inspection Room to host the FDA inspector, a Ready Room for preparing interviewees and a Back Room to ensure that requested documentation can be made available in a timely manner. The mock inspection should include participants in all key roles, including an inspection host, a representative from Quality Assurance, functional leads, subject matter experts, scribes and runners. Furthermore, the mock inspection should enact the entire inspection request process, including CRO and vendor requests. All participants should understand that a mock inspection requires preparation. It is a dress rehearsal for the real thing, not a first attempt to explore potential issues. A realistic mock FDA GCP inspection typically will take 2-3 days. Following the mock inspection, it is important to evaluate the processes used as well as the performance of the participants and the availability of supporting documentation. A summary debrief of the mock inspection is best scheduled on a separate day. Such a debrief is invaluable for identifying training needs and potential operational issues to be resolved prior to the FDA GCP inspection.

Tip 6: Ensure the Availability of an Experienced FDA Inspection Host or Co-Host to Manage the Inspection

Following the steps outlined above, the program manager or an internal designee such as a Quality Assurance manager may be comfortable hosting and managing the FDA GCP inspection. However, depending on the experience of the sponsor team and performance during a mock inspection, it may be advisable to bring in an independent cohost to assist in hosting the FDA inspector and managing the inspection process. This is especially true if the mock inspection did not go smoothly. Furthermore, it may prove challenging for a single person to serve as host to the inspector, manage the processes established for responding to inspector requests and conduct daily debriefs to ensure that any outstanding issues are understood and addressed in a timely manner.

The optimal team for hosting and managing the FDA GCP inspection will likely become clear following a realistic mock FDA inspection. Preparations for the inspection should include signage to ensure that staff understand that an FDA inspection is in progress. It is important to maintain a log of inspector requests and to identify any outstanding requests at the end of each day. This increases the likelihood of resolving all issues before the FDA inspector leaves the facility. To ensure adequate preparation for and response during the inspection, it may be best to work with a partner that can provide comprehensive inspection management and preparation services. Such services would include preparation for the inspection, rehearsal of the inspection and management of the actual inspection.

Preparing for and hosting an FDA GCP inspection is a complex undertaking with high stakes. The six tips in this series of articles provide a concise roadmap for inspection readiness and management. Since each development program is unique, the detailed requirements for inspection readiness and hosting must be as well. But one thing is clear: a program manager will benefit greatly from the participation of a colleague or consultant with previous experience managing and hosting sponsor FDA GCP inspections.