FDA inspections: trials, tribulations, and successes

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Inspections from regulatory agencies can be some of the most stressful periods ever experienced for some individuals and some plants.  After all, these inspections can determine, literally, the future of the site.  A successful pre-approval inspection can mean the difference between prosperity or struggles in many cases.  For more established sites, a successful inspection can strengthen your compliance reputation or help foster a new culture of compliance.  And, a solid inspection can serve as validation of the hard work expended to properly manage compliance enhancement and inherent compliance risks.

Though much has been written about preparing for and managing inspections, I would like to pass along a few perspectives I have gained over the last few years.  These hints might be helpful as you prepare for your next visit:

  1. Confidence is a major contributor to successful inspection results – Let’s face it… the end result of most inspections occurs, not because of tremendous management of the inspection, but because the site has prepared, individuals have diligently documented their work, and you have a stellar culture of compliance at the site. When you have prepared well, your inspection management team operates with more confidence.  Investigators are trained to observe for this confidence and look for signs of concern or weakness.  Being able to confidently present site results and a strong GXP compliance position significantly supports a successful inspection result.
  2. Managing the logistics of FDA inspections is becoming more and more important – Regulatory investigators are becoming more and more demanding about the speed of producing documents and whether or not the site was completely forthcoming regarding answers to questions.  With the implementation of new FDA Guidance documents, FDA is now more aggressive about what they have access to, how quickly documents are provided, and who and how questions are answered.  Speed is becoming almost as important as accuracy during the actual inspection, though I would choose the latter over the former, if a choice was absolutely essential.
  3. Managing the investigator (or team) is essential – Because of the challenges posed by the need for speed and accuracy in producing information , it is becoming even more crucial that you properly manage both the front- and back-rooms during inspections well.  If you have not rehearsed this recently, it might be worth doing so again, especially if you have new individuals involved.  Understanding the mood and demeanor of the investigator is important, as well.  Pay very close attention to body language, expressions, and comments made by the investigator as the inspection progresses.
  4. Remain calm and professional despite potential threats or intimidation – I have heard from industry colleagues examples in which an investigator made a number of comments during the inspection about demanding a recall, escalating items to the FDA manager, or even going public with information.  Knowing that the investigator does not have the authority for much of this makes it essential that you remain calm and professional and not lose your focus.  It is possible that an FDA investigator would occasionally use such techniques to get the plant to share information that they would normally not share.  However, remaining calm can help shift the inspection back to a less stressful relationship.
  5. Do not be pressed into making unnecessary commitments – You must never make hasty commitments during an inspection without full knowledge and approval from your senior management.  The FDA investigator may attempt to get a verbal commitment from you that they can include in their report.  It is important to always state that you will respond appropriately when needed and after full collaboration with all functions necessary.
  6. Focus on the science, adherence to GMPs, and patient safety – You need to remember that the first priority of FDA or other regulatory investigators is to ensure public safety.  With this in mind, you can often produce information that can negate the concerns of the investigator.  When they realize that there is no public safety concern, the level of alarm often immediately diminishes.
  7. Thoroughness of your investigation reports remains important – Every investigation involves the review of investigations (OOS, Exceptions, Complaints, etc.).  This is a focus for every investigator.  Thus, you must remain ever diligent in conducting these thoroughly, documenting all your actions completely, and ensuring that the reports tell a full story.
  8. You should have a significant team to back you up – Inspections often move into areas outside the responsibility of the inspected site that requires expert assistance.  For example, questions may arise regarding regulatory filings that require assistance from the off-site Regulatory Affairs function.  Or, you may need R&D assistance to answer detailed product questions.  Remember that you must defer to these experts, when necessary.  Attempting to provide answers without proper input can result in issues.  One note of caution, though, is to ensure that you prepare any individuals from outside the site that speaks with the investigators.  Prepare them in advance similarly to how you might prepare a site subject matter expert before bringing them into the inspection.
  9. Stay focused to the end – Some regulatory inspections can continue for weeks.  During an extended inspection, your team may become “comfortable” with the investigator and, as a result, let down their guard.  You must be diligent and focused all the way to the end!  I have seen inspections that went very well all the way until the last day when significant issues were raised.   Allowing team members breaks during an extended inspection can help keep them fresh and alert.  Staying focused throughout an extended inspection is a challenge, but you need to remain on-guard and at-the-top-of-your-game all the way to the end.

Most inspections have moments of trial and tribulation.  But, if you remain diligent and focused, you have a greater probability of best representing your site and its GXP performance. Your ability to adequately prepare and foster an ongoing compliance culture now will pay off the next time your site receptionist calls with the exciting news, “Two individuals from the FDA have just arrived.”  Good luck on your next inspection!

 

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