In our GMP News from 20 October 2010 we reported in detail about the consequences of an FDA inspection. But how do manage an inspection yourself? For some companies this can be an important question to survive.
On its Medical Devices website the FDA provides some information on close to three pages on how they imagine a FDA inspection, using the example of a "Medical Device Sponsor Inspection". Although the document refers to the "Bioresearch Monitoring Program (BIMO)" of medical devices, many of the tips can also be transferred to an FDA inspection in the medicinal products sector.
The document starts with "FDA is coming!" In many companies this notion triggers plenty of activities - and sometimes even "hyperactivities". The document itself refers to the contents of the BIMO Program and describes the goals and contents. The first interesting item is "Inspection Preparation" already. Here the FDA recommends that the top management is available during the day of inspection. This seems to be a good advice as there were deficits in the past. It is also recommended that staff knowing the study should be present as well. Transferred to staff in the medicinal products area this means that persons familiar with the internal GMP aspects should be available. Sound trivial? Not at all. Please also consider substitutes for staff on vacation or on leave due to diseases. Quite a few deficiency reports during inspections are based on misunderstandings due to inadequate explanations from personnel that was trained insufficiently or completely wrong. The FDA further recommends a quiet area with access to a copy machine to be able to "review" documents. This advice also appears to be basic. However, an acceptable inspection atmosphere can already be a big part of a (successful) inspection. And an appropriate environment is part of that. Just imagine, would you like to review documents in a small and muggy room without any windows, possibly with inappropriate air conditioning? Another tip is the availability of SOPs - also a very practical advice. If you constantly need some time for providing the required SOP, you can easily be blamed for time delay.
The item "Inspection Day" then briefly describes the course of the inspection day. Here the FDA also provides practical advice and proposes to review the "findings" at the end of every inspection day. This is really an important tip as it opens the opportunity to correct "findings" until the end of the inspection.
"What do we inspect" is the headline of the documents the FDA wants to review during BIMO inspections. Again, transferred to the pharmaceutical environment this means organisational charts (a personal note: please provide current documents!), supplier agreements, monitoring plans and reports. Others are qualification documentations, training documentations and, again, SOPs. In short: Documents that are related to the inspection cause.
Following, the inspection result, the measures following the inspection and the classification of the inspection are illustrated. Please also see the news from 20 October 2010 where this is also pointed out in more detail.
"Common Sponsor Deficiencies" then refer to BIMO - with very few parallels to the pharmaceutical area.
This is not true for the items "Written Response" and "Points do consider", though. Here the FDA provides detailed tips for responding 483 deficiency reports, which are also helpful in the pharmaceutical environment. For example, there is advice to mention a "root cause" and the according CAPA measure. The document even provides a sample response to a deficiency.
And what else is to be considered? Be polite and respectful when dealing with FDA personnel. You may want to simply switch sides for a better understanding. Possibly the FDA inspector(s) is/are on site in an unknown operation in a foreign country and have to make sure that more than 300 million of Americans receive secure APIs, drugs and medical devices (depending on what you produce). This is a tremendous responsibility, and one should thus show the adequate respect.
The overview ends with the sentence you may alreay know: "If it is not documented, it didn´t occur!" This is a fact that still is the reason for many failures.
Conclusion: The document offers a good overview, especially for persons who do have little experience with FDA inspections. It can also help those experienced with audits to refresh their knowledge, though.
For further information please also see the document.
On behalf of the European Compiance Academy (ECA )