It is important during an inspection to have a well-oiled strategy that has been honed and practiced with the site inspection team. To do otherwise will surely get you into trouble and that could be costly both monetarily and in terms of establishing a good compliance record and credibility with the regulatory agency.
In preparation for your inspection it is important to know what the FDA inspectors can request. Only if you do that will you stand the chance of navigating the process successfully.
So, what can FDA request?
They can request to look at documents connected with:
1. Equipment
2. Materials
3. Products
4. Labeling
5. Clinical documents
6. Manufacturing and testing documents
7. Quality system documents
8. Research and development data/reports
9. Management reviews
One contentious area is associated with internal audit reports. FDA has only limited access to these reports and these six circumstances are specified as described in the following policy guide.
www.fda.gov/ICEI/Compliancemanuals/CompliancePolicyGuideManual/ucm07841.com
However, other agencies including EMA & MHRA can request these! So why is this important? It is important because FDA has cross agreements with these and other agencies, so if they really want to look at these audit reports they can probably request them from these other agencies.
So, the take-home message then is “Make sure that these are in order and that anything that may have been raised in them has been appropriately acted upon and closed out.” With this in mind then, it is a sensible policy and sign of goodwill, if you work with the inspectors rather than refuse them when they request
documents.
Today, building a “Culture of Quality” is paramount in the eyes of the FDA.
Fundamental then is the need to build quality into your process and associated
systems that support that and those processes.
Evaluating your infrastructure for inspection support is one area which can
contribute to providing stability. Critical in doing this is to perform risk
assessments to flush out potential weaknesses. By completing appropriate impact
assessments one can assure whether an issue is likely to affect a single system,
many, or your product directly. Once this is completed, then developing the
appropriate corrective actions against exposure points will be risk the probability
of a negative finding during an inspection.
These are all good actions, but to build a true “Culture of Quality” it is vital to
maintain a continuous program to test your systems to assure that you always
stay ahead of the compliance curve.
Important to note however, is even though your company may receive a positive
inspection result, it is important that you do not take your foot off the gas so to
speak. Vigilance is your ultimate insurance for your manufacturing operation and
to neglect this will eventually cause bad things to accrue. Remember, weak
systems will eventually fail when they do you will manifest deviations, recalls
import bonds and eventual federal seizure of your product.
From our experience, a major reason these things slip through the net is because
of complacency, usually after a sequence of positive regulatory agency
inspections. Objectivity is therefore the order of the day and nothing achieves this
more appropriately than through the fresh eyes of a pharmaceutical consultant.
Think about this as you develop your inspection readiness process as it is an
inexpensive option compared to the downside.
