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A panel of longtime industry experts offer manufacturers a list of things they should and shouldn’t do when an investigator from the US agency knocks on their facility door. In this first installment of a 10-part series, a procedure for hosting inspections is addressed.



A panel of longtime industry experts recently convened to give manufacturers advice on the 10 best and 10 worst things they could do during an inspection by the US Food and Drug Administration.

Offering tips in Part 1 of our series is David Elder, executive VP for consulting firm Greenleaf Health, and a former director of the FDA’s Office of Regional Operations within the Office of Regulatory Affairs (ORA); John McKay, CEO and chief compliance officer for consulting firm Q1 Associates; and Susan Schniepp, a fellow at Regulatory Compliance Associates.

Here is the first item on their list of inspection do’s and don’ts:

No. 1
> BEST PRACTICE: Establish and follow a robust procedure for hosting FDA inspections.

> WORST PRACTICE: “Wing it” by not using an inspection SOP when agency investigators visit your site.

Elder: “Here’s my advice: Having an inspection procedure, training on it and following it in the heat of battle – aka, during an inspection – is certainly one of the things that we all believe is appropriate. And the converse, thinking you don’t need a procedure, is inappropriate.”

McKay: “Many firms have an SOP called ‘Hosting Audits and Inspections.’ The SOP will include things such as a list of inspection participants – the scribe, the runners, and those people working in the front room and the back room.

“When you do that, you can show the SOP to the investigators and explain to them: ‘This is how we host our regulatory inspections. This is the procedure we’re following, and this is the list of things that our scribe is capturing. And we’re doing this to better serve your request, to put our best foot forward by explaining our management systems – and our records – to you so this inspection is most efficient.’

“Now, keep in mind that these investigators all have different personalities. Nowadays they’re trained better, and they’re trained on how to ask questions. But they are going to have some skepticism. They’re going to have a trust-but-verify attitude. So, the more open you can be about your process and explain it to them, the better.”

Schniepp: “I’m going to tell one of my most embarrassing moments. It was my second day on the job as VP for a company – it was a small company – and the FDA came to inspect. And I thought, ‘Well, I haven’t been trained. I don’t know anything. So I’ll observe my director of quality while he handles this audit.’

“And he was very proud of his SOP, which was about how the firm handled inspections. He gave it to the FDA investigator, who read it and saw the line: ‘Don’t lie to the FDA.’

“Well, to say the least, I sat there thinking, ‘Oh my gosh, why is that line in the SOP?’ After all, if you put that line in an SOP that explains how the company handles regulatory inspections, the investigator is going to wonder exactly what we’re doing the rest of the time that we need to remind our employees not to lie to the FDA.

“So, remember that when you write SOPs, when you’re dealing in an inspection, it’s all about perception and putting your best foot forward. Don’t write SOPs like you’re reading them. Instead, write them like someone else is going to read them – because they are. And especially don’t include the line ‘Don’t lie to the FDA’ – because you shouldn’t be lying, period.”

The comments from Elder, McKay and Schniepp came during FDAnews’ 14th Annual FDA Inspections Summit.

[Editor’s note: In Part 2 of our series, the experts address the do’s and don’ts of preparing and maintaining a site overview slide deck that firms can show to FDA investigators during an inspection’s opening meeting.]

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