—-Be prepared, the FDA cometh!

In preparing for your facility audit, the FDA will spend up to 16 hours covering information from a variety of sources. They will look at your product submissions and registrations, key suppliers and collaborators, like your CMOs and testing houses that you may be using your product. They will look at your previous inspection history, including any 483’s, previous EIR’s, Warning Letters or import bans that may have occurred or have been accumulated.

The records that may be searched would include any recalls that have been sustained, adverse event history and financial information such as stock exchange transactions and records.

Another source which is often overlooked is that inter -regulatory agency records can be exchanged and these become available from sources such as EMA, Health Canada & MHRA.

So, the FDA is extremely well briefed and prepared before they come to your site.

In terms of process methodology, the FDA follows a systems approach to assess quality prior to them looking into problem areas. Using a systems approach, the inspectors reached down into each subsystem by sampling various records. In doing this they will frequently look at common areas of weakness in separate subsystems to highlight a systemic failure, or apparent weakness in the overall quality management system.

With this approach, the FDA performs verification analysis to assure that the things that have been completed are indeed complete and in conformance with the regulations.

For example, they would verify that non-conformances have been properly defined, documented and completed. They will provide assurances that nonconformances be properly identified and addressed. They will confirm that the verification process has utilized appropriate statistical methods to detect recurring quality problems, and that proper failure investigation procedures have been followed.

Some of this verification will include a review of the timelines for document generation /approval to assure that they are logical and timely. There will be verification that appropriate actions are being taken for the correction of issues associated with nonconformances, and what corrective actions have been initiated, including that they have been validated prior to implementation, as well as being appropriately documented.

To assure the engagement of senior management is apparent, they will examine whether serious nonconformances have been circulated to senior/executive management for notification and appropriate action. For this, objective evidence that the executive team has been properly engaged will be required.

It should be recognized by the site that the FDA inspectors will be very well prepared on arriving at your site. They will be trained in the new inspection process for which a new internal guideline has been generated. Therefore, you will need to be equally prepared to successfully negotiate and navigate the FDA inspection process.

In preparing for the inspection it is appropriate to develop an internal SME team that will spearhead the site process. In assembling this team a characteristic we should be high on the list of desirables should be the competency of an SME to answer investigative questions, specifically those connected with areas of risk.

Performance under stress is not a universal human quality and so it is appropriate to not only pick SMEs that have high technical competency, but also those who can remain calm in a high pressure situation that could be emotionally intimidating. It is important at all cost not to have panic anywhere near the inspection process.

As in any human interaction personal demeanor and attitude can play an important role in how a situation can play out. So, it’s important to be professional in one’s approach and to remain confident throughout all situations where there are SME/FDA inspector interactions.

Often ignored, but a basic technique that should always be maintained to help assure honesty and integrity is to maintain good eye contact with the investigator, in addition to speaking clearly and with authority. These principles together with the knowledge of the subject matter will help gain trust and respect, which will go a long way in helping to assure a smooth inspection process.

These are all simple points of preparation but done well can make a world of difference to helping to manage a successful site inspection.

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