Did you miss our last blog on PAI Readiness? Catch up here to learn what a PAI is and how to prepare.
Congratulations! You conducted a Mock Inspection in preparation for your upcoming Pre-Approval Inspection (PAI). This is a crucial step in PAI Readiness. Question is: Now what? How do you address the findings of the Mock Inspection without severely impacting your portfolio’s progress and without overworking your already taxed staff? After all, they need to be inspection-ready at all times while also supporting day-to-day business. Successful post-Mock Inspection activities start with planning prior to initiating the PAI Readiness initiative. This starts well before the Mock Inspection.
Planning and Conducting Your Mock Inspection
Treat PAI Readiness like a Project
- Treat it like a project by utilizing a Project Manager to lead the effort
- Identify the scope, create a plan, create a schedule, and prioritize the execution and the resources dedicated to this effort
- Initiate the plan appropriately, execute against the plan, monitor, and continuously verify the health of the project, and close it out appropriately and absolutely
- Get Stakeholder and Site Leadership buy-in to prioritize PAI Readiness
- You can do this by using a Project Charter
- If the PAI is not successful, you can forget about any future development, products, or projects
- Closure of PAI Readiness activities and Remediation equals success. Don’t forget: A CAPA for each activity can drive closure.
Plan Ahead (“If you fail to plan…”)
- Conduct the Mock Inspection well in advance – about 1 year before you plan to file
- If you give yourself enough time, you just may be able to complete any required remediation with internal resources
- You won't overwork your staff who already have daily responsibilities and projects, by tasking them with PAI remediation efforts at the last moment, prior to PA
- You will know what, if any, additional inspection training is required
Oh, you didn’t plan your Mock Inspection in advance? Don’t worry, there is still time for a successful PAI.
You Left It to the Last Minute (“…you plan to fail”)
So, you have not planned appropriately and don’t have 1+ year to complete the Mock Inspection and required remediation? It is not too late to ensure a successful PAI. To avoid reprioritizing the work of your internal resources and potentially taxing them with additional work and activities, there is one simple solution: rely on a trusted partner. Bring in a trusted partner to help you plan and execute the Mock Inspection and remediation with minimal interruptions and minimal commitments from internal resources. This should be an independent consulting firm that has the correct knowledge, understanding, and experience with PAIs. Your external resource should be well-versed in audits and inspections. Additionally, the external resource should have direct experience in not only US-based PAI (with the FDA), but additional experience with other Regulatory Agencies (Europe’s EMA, the UK’s MHRA, Australia’s TGA, etc.).
Additionally, don’t forget your partners. The CROs, CMOs, testing laboratories, etc. you work with need to be PAI-ready too.
Conducting the Mock Inspection
Ideally, the Mock Inspection should be conducted by or alongside a trusted partner, as defined above. It should not be conducted by an internal resource but rather by an independent, non-biased third-party resource to ensure it is treated like an actual Inspection. Inspection training should be conducted well in advance of the Mock Inspection. Although the Mock Inspection will be an invaluable training tool, it will not be the sole training provided. In other words, Mock Inspectors shouldn’t take their Inspector “hats” on and off. They should conduct the entire Mock Inspection like a true inspection.
The Mock Inspection will identify the process, facilities, procedures, etc. that require remediation or optimization. The Mock Inspection report will outline the criticality of the findings in order to help outline the work required by you, as the facility undergoing an upcoming PAI, to complete.
After Your Mock Inspection
Assess the Risk
After receiving the Mock Inspection report, it is now time to plan again.
- Outline all the findings
- Prioritize the findings according to risk:
- Critical Risks should be Priority 1
- Major Risks should be Priority 2
- Minor Risks or optimizations that are considered “Nice to Have” should be Priority 3
- Remember: CAPAs are a great way to track progress and closure of any findings!
Execute Against the Risk
Items that are Critical (Priority 1) must be addressed before submission. This ensures that items that truly need remediation, rather than optimization, are completed in time for the PAI. If you plan on completing these tasks prior to the submission, you ensure success. Items deemed as Major (Priority 2) should be addressed prior to the submission or have a CAPA initiated, in the event that execution can not be achieved by the time of the submissions. All others can wait to be completed at a later time, assuming any risk is appropriately mitigated and appropriately addressed/documented.
Train, Train, Train
You may have a lock-tight filing. Your data may be meticulous. You may have all the best responses to any Inspection question, but none of that matters if your SMEs do not know how to present themselves and the information to the Inspectors. If your capabilities can not be appropriately articulated during the PAI, then you are back to square one. To that end, ensure you conduct Inspection Etiquette training and refresher training closer to the PAI. Ensure your SMEs and all employees know the purpose of a PAI and what can be reviewed by the Agency. Ensure they know your Inspection procedure and they know where to report if called upon.
Once you submit your filing, do not assume that you will have time to assess readiness and perform required remediation. Plan ahead. Assume that the Regulatory Agency can, and may, arrive for an inspection as early as 1-week post-submittal. This likely won’t happen, but you never can tell. To ensure your PAI success, be ready well in advance and work with a trusted source to ensure your Pre-Approval Inspection will go smoothly.
Look for our final installment of this PAI Readiness series, coming soon! In the upcoming blog, we will dive into PAI readiness when partnering with a CMO to ensure you are aligned and demonstrating adequate oversight.
