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Preparing for Your FDA Inspection
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.
END
.