What Can I Do to Get Ready for a Quality Audit or FDA Inspection?

Audits are strategic and require planning

Quality Audits and Inspections play an important role in any regulated industry. For pharmaceuticals, biologics, devices, IVDs regulated by the US FDA or other regulatory agencies this is simply a fact of life. While all of us want to live in a perfect world where their facility is always “inspection ready” the truth is that for over 80% of the companies I have worked with this is just not the case. My old mentor at Abbott Laboratories use to say that our goal was open book compliance, meaning that at any point the FDA, TUV, CMDCAS, or BSi could walk in our front door and we would simply open all of our records and let them inspect at will. The harsh reality is that most companies are far from open book compliance. Audits are strategic and require proper planning. It is important to put your best foot forward from day one, establish that you have a strong quality system, and demonstrate that your processes are under control. I have seen many inspections go terribly wrong and most of these were from a lack of preparedness.

Who needs to be Inspection Ready?

Inspection readiness applies to internal quality audits, corporate audits, due diligence audits, and external audits (or inspection) conducted by regulatory agencies or notified bodies. Audits conducted by manufacturing partners or customers are equally as important. This article focuses mostly on external regulatory or notified body inspections, however the strategies apply across the board. The checklist can be used for FDA inspection readiness as well an internal quality audit preparation.

Why use a checklist?

I have been doing this for over 17 years and I still use a checklist. Things are easily forgotten and something that may be updated and clearly documented at one site may be completely overlooked at another. A checklist will help keep you organized and it will help ensure that all team members have clear assignments and are accountable for their tasks. I also recommend weekly dashboards or a scorecard showing the progress of these tasks.

Inspection Readiness Checklist

See full checklist available here.

Known gaps and deficiencies?

I have been to device companies that have never conduct Management Review, I have been to pharma companies that were grossly out of date with their Annual Product Reviews (APR), and I have seen companies with open, uninvestigated, CAPAs that are over three years old. The important thing is to identify these gaps early and be proactive. Open a CAPA now, begin to address the deficiency before the inspectors arrive. Have a plan of action and if there is a significant gap such as a lack of validation, lack of data, etc. write a plan to demonstrate how you will address this gap and in what timeframe.

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