2. You asked for it Wanted more review of the steps involved
This series is designed in parts Part 1 Preparing for the FDA Part
2 What to do when the FDA arrives Part 3 What to do while the FDA
is there Part 4 What to do during closeout Part 5 What to do with
the 483This is Part 1 Preparing for the FDA 3. People always ask me
Troy, what is the best way to deal with FDA issues? I usually
sayDont have any That being saidthere are things you can do to
mitigate the potential for you and your firm to have any serious
FDA problems. Lets start with the obvious: Did you have previous
483s or Warning Letters? If so, did you do everything to which you
committed in the response? If not, did you inform the FDA of the
delay. During the audit is not the time to find out you have issues
Will the next audit be general GMP? For cause? PAI? If the
inspection is going to be focused you can focus your attention to
getting those things ready. Dont forget you could always have a
general inspection even during a PAI. 4. Your facility should
always be ready for an inspection! Butit is always a good idea to
go through the facility to see how things look. Working in the
factory every day can dull your senses to problems that might have
slowly developed over time Have someone new go through the facility
Develop a tour plan for the areas who will lead the tour in
different areas? What pathway to take (just remember the FDA can
always go where they want within reason)? Any signs of leaks in the
ceiling? Cracked walls? Pealing Paint? All signage in place?
Facility registration up to date? How does the exterior of the
facility appear? Remediate anything possible!! Key is that
everything should look organized and in CONTROL! 5. Look at how you
are making the product(s) specifically on the high risk processes.
If you have a PAI, focus on the product in the filing. Are you in
CONTROL? How do you know? Does the process match what you have
filed? Do the SOPs conflict with the process? Is your APR (annual
product review) process up to date?Have you maintained a good
change control system? 6. Are people trained? How do you control
training updates to SOPs? Annual GMP training performed? How do
batch record errors look? Lots of errors or fairly clean? Do the
investigations often site people as the issue? If so, then you have
an issue. Who are the folks that you will use as SMEs? 7. You need
to check a lot of other items in preparation for the audit. You
know your system check those areas that have potential for the
largest impact. Warehouse practices Customer complaints Validation
equipment, process, cleaning, utilities, etc. Lab operations
Calibration Pest and rodent controlThe key? Show you are in
CONTROL!! How do you know it? 8. Call us at 513-860-3512 See our
website at www.Compliance-Insight.com Send us an email at
[email protected] for watching!
