Bioequivalence and Bioavailability Forum

❝ precaution while USFDA audit for BA/BE trial in my compony

Hi,
Dr.
U can conduct pre inspection audit by the third party consultant.
there r certain crucial ponits which needs to be followed/maintained during audit. It will be too long to discuss such matter over hare.

Debabrata

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Edit: Original quote restored. Please see also here. Hare? [Helmut]

Dear Dr Niraj,

As I heard a Swedish inspector once say at a DIA meeting: don't worry, it's too late...

Main recommendation: don't try to cheat, to lie to them, or to make up any document for the inspection. They may not realise it, but if they do, that's the end. Make sure all staff are aware of that. Though inspectors are paranoiacs and won't trust anything unless it is written, an inspection remains a confidence-building process. If somebody cheats, the inspectors will just become even more paranoid, and they may just decide that they can't trust your documents and data, even if this was just for a totally minor and insignificant detail.

Don't take this recommendation as an insult or anything. That's just a temptation some people may have when they realise that something was maybe not done as it should have been, or not optimally. One person making that mistake at any level in the company, without telling anybody, could ruin the whole process and your reputation.

A few other points:

If you don't understand a question, or if you are not sure you have understood it correctly, ask for a clarification. Possibly re-phrase it to make sure you got the point. This is better than giving a wrong answer, which could give a wrong impression.

At the end of each day ask whether there is any outstanding issue which would need to be solved, or anything to prepare for the next day. Try and solve problems on an ongoing basis.

Pay a special attention to the record of inspection observations (FDA-483 form), if you get one. That's the written document you may get at the end of the inspection, if they find any "objectionable condition". If there was any misunderstanding which you can clarify, or if you can solve one issue immediately, do it before the end of the wrapping-up meeting ! You may manage to get it removed from the 483 form. You have the possibility to respond to the form in writing, do it ! Ask the FDA guy what the deadline is for that. And if you plan to take any corrective action, explain that in detail in your response, including timelines.

Regards
Ohlbe