Post FDA Inspection Activities

After the inspection is finished, you will probably findPLAN OF ACTION: After the inspection, changes will
yourself with a lot of things to be corrected, either inbe expected from you and your company. An
the process, system, documents, or in relation toexcellent way to show the FDA that you are on the
your cGMP compliance program.. Don't let panic getright track is to accompany each response to 483
hold of you, this is normal, and you can still implementitems with a clearly defined, reliable, and scientifically
some remedial actions to overcome this situation.justifiable plan. The timelines for implementation need
It is important to note, however, that perfection isto be clear and realistic and the language to be used
not probably possible at the preapproval stage, asshould be very specific. Avoid using general
there are too many variables to be considered. Asstatements, as they will sound too vague and untrue.
your pharmaceutical consultant may have warned5. INFORM THE FDA IF YOU MISS THE DEADLINE
you, most of the issues sometimes deal with theFOR IMPLEMENTING CORRECTIVE MEASURES: If
way of presenting facts, figures, and documentation,the corrective measures are taking too long in the
rather than the real content of the data itself. Someimplementation, you should inform the FDA and
consulting firms in the pharmaceutical business haveexplain what has happened. Tell them also what your
specialized in inspections, and here are some remedialnew timeframe is.
tips for your FDA preapproval inspection results:6. HAVE 483 RESPONSES FILED TOGETHER WITH
1. MAKE A FORMAL RESPONSE TO ALL 483 ITEMS:483 REPORT: You can request that the responses
10 to 15 days after the inspection, send a formaland 483 report be filed together. It is easier to keep
response to the FDA district. Though not legallytrack of all items and corrective measures, and this
required, this action will clearly show your company'sclearly shows that you are making big efforts to
good intentions and may also diminish the possibilitycomply with regulations.
for further regulatory action. It will definitely cause aRemember that the 483 report and EIR will be
good impression at the FDA.available under freedom of information legislation, so
2. RESPONSES SHOULD REFER TO BOTH PRODUCTit is vital for you and your company to have a copy
AND SYSTEMS: Although you are looking for theof the FDA establishment inspection report. That
approval of a product, the inspection results mayway you can read all of the inspector's additional
have thrown some faulty procedures in data handlingcomments and concerns, and you can use this
or other parts of the whole quality system. Youmaterial for further inspection preparations. Don't let
want to show not only that your product is good butthe inspector's findings bring you down. Take their
also that the system you use can be improved tocomments as motivational tools to improve your data
reach compliance with the highest standards.handling, careful SOP implementation, and preparation
3. ATTACH COMPLETE AND AUTHORIZED COPIESfor regular inspections. The highest standards need
OF SOPs: Remember that any discrepancy betweenmore than one step to be achieved. You are just
presented SOPs and actual behavior (processes) willtaking the first steps to get there.
alert the inspectors. If their observations during theIf you enjoyed this article about a pharmaceutical
inspection include missing documentation such asconsultant, please feel free to post it to your site or
Standard Operating Procedures, you'd better write,blog and forward this link to to your friends. Have a
approve, and implement relevant SOP and attachgreat day!
them to your first response.Don't forget to visit our blog.
4. ACCOMPANY ALL OBSERVATIONS WITH A