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Preparing for Your FDA Inspection
Preparing for Your FDA Inspection
If you sell medical devices in the USA, the FDA is coming. Whether you are
located in the United States or in Europe or elsewhere abroad – you must be
prepared. Making some last minute preparations could mean the difference between
a good audit and one with a multitude of 483s.
It’s Like Running A Marathon
You wouldn’t expect a marathon runner to go into a race without having prepared
along the way. In fact an FDA inspection is very similar to running a marathon –
in as much as the analogy for preparing. There are two very important
similarities that make running a successful marathon and having a successful FDA
audit become a reality.
1) Don’t wait for the last minute to prepare. Like a successful marathon, you
must condition your organization into compliance.
2) And second, just like the way a marathoner prepares for the big race, you
will need to take specific steps in preparing for the actual audit.
This article will concentrate mainly on the second element of preparing for the
big one. However, this may be useful for establishing a gap analysis. It is
highly recommended that you go through mock inspections on a routine basis.
FDA Inspections
Never gauge the expectation of an FDA audit by previous audits. Auditors are
like fingerprints; you never find any two the same. Interpretation of findings
is for the most part determined by the experience and knowledge of the
inspector. In most if not all cases the auditor will have had at least the basic
training and should be able to smoke out the worst of your organizations closet
skeletons. When preparing for an audit always assume that you will have a
seasoned highly knowledgeable auditor. It's better to over-prepare than to
underestimate the extent of the inspection.
QUALITY SYSTEM INSPECTION TECHNIQUE (QSIT)
If you are new to the whole FDA inspection system or if you've been away from
the process for some time - you should take some time to familiarize yourself
with the Agencies procedures. When they come - FDA field staff may use the
method known as the Quality System Inspection Technique (QSIT) to evaluate your
compliance to the Quality System Regulation (QSR). QSIT allows the investigator
to focus on particular elements of your quality system making for a
comprehensive overview. There is a definite benefit when you know ahead of time
what the questions are going to be! Unfortunately, many organizations do not
take the time ahead of time to prepare for the questions.
How does preparing help?
Knowing what questions will be asked allows you to prepare the response ahead of
time. You can collect the necessary documents and present them to the auditor in
a timely and efficient manner. Some people being audited may think this is a
negative thing. They think erroneously that presenting information too quickly
allows the inspector to look at more documentation. This is false. What it does
accomplish is an overall impression that the firm is in control of their
processes and more importantly in compliance with FDA's QSR. Taking too long to
obtain requested information can frustrate the FDA inspector and may lead her to
think that you are trying to intentionally suppress the information.
Preparing in advance and knowing what questions the auditor is going to ask also
helps alleviate some of the stress associated with anticipation. It really is
fear of the unknown. If however you take the time to go over the QSIT questions
and construct the associated answers you will find that you don't feel as
stressed. And of course you will feel more confident in yourself and this will
definitely be conveyed to your auditor.
What Questions Will the FDA Probably Ask?
The QSIT script is available on the FDA's website at the following web address:
http://www.fda.gov/ora/inspect_ref/igs/qsit/qsitguide.htm
If you haven’t done so already download a copy! It’s free! It tells you (most
probably) the questions the FDA is going to ask. It’s like getting the questions
to the final exam!
The Scribe: Keeping A Record of your FDA Audit
Maintaining a detailed record of an FDA audit is important. The outcome of an
audit may vary depending on many circumstances and in some cases may result in
observations that may have been taken out of context by the auditor. A good
record will allow you to double check the circumstances surrounding the
observations by the FDA and if applicable this can provide you with information
you can use to contest an observation. Another important reason to keep a good
record is to allow you to go back and observe what you did wrong - or did right.
During an FDA audit it would be wise to have a member of your staff act as a
scribe. Having someone else who is solely responsible for taking notes allows
you and the other members to fully devote your attention to the auditor. The
scribe should take detailed notes with regards to what the auditor observes and
does. For instance if the auditor looks at any particular products during a
facility tour, your scribe should take note of the lot numbers, etc. If the FDA
elects to take samples, you should definitely keep a record of what was taken.
The scribe should note all the documents that have been reviewed by the FDA. In
additional all copies of documentation taken by the FDA should be stamped as
"Confidential" (especially if they are proprietary) and preferably photocopied
(and kept by the firm) or at the very least keep a detailed account of what the
FDA has taken (including version numbers in the case of procedures). The
"confidential" stamp tells the FDA that the document they are looking at may
contain proprietary information. This will keep the information from being
readily accessible by way of the Freedom of Information (FOI) act.
Your scribe should also take careful notes on who participates in the audit. At
times you may call on to different members of your organization to come and
discuss certain aspects of the business to the FDA. Your scribe should note the
names of all participants including those that come in contact with the FDA
during your facility tour. The scribe should also note what the participant
does, says and provides to the FDA.
You may want to choose your scribe very carefully. It would be best to select
someone who is very knowledgeable of FDA requirements as well as your own
procedures. The reason for this is that a knowledgeable scribe can make detailed
observations that involve close calls and other activities that are of a
noncompliant nature. For instance while you are busy explaining some part of
your process to the FDA inspector there may be someone in the facility that is
violating some important GMP requirement.
During the course of an audit you may make promises or suggestions to the FDA.
Your scribe should be instructed to take note of these. It goes without saying
that you should only promise to do something if your intent is to do it. The FDA
will hold you to your promise. Make sure your scribe notes these commitments.
Finally it is recommended that you take note of all FDA
recommendations/suggestions.
It goes without saying that you probably need to go into the audit with the
anticipation of recording everything.
Conclusion
One final word: It is recommended that you funnel all the answers through one
person at a time. The person answering the questions should ensure that the
communications to the FDA are kept laconic and honest. Avoid small talk.
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