A group of industry insiders shared their outlook at the recent Rocky Mountain Dietary Supplement Forum, held in Boulder, Colo. On Sept. 13 and 14. The agenda looked at many aspects of the GMP inspections process, and one mantra was heard over and over: Practice, practice, practice.
“It’s very important to have a standard operating procedure (SOP) for FDA inspections in place,” said Shelly Maifarth, one of the principals of FDA Compliance Group, the Colorado-based consultancy that held the event.
“The receptionist needs to know who to call if FDA shows up. Have an SOP in place and practice it. It’s kind of like the fire drill in elementary school,” she said.
Some who block, some who tackle
That SOP should specify a team to deal with inspections, said Cindy Beehner, principal of Pennsylvania-based QSD Consulting, who was one of the presenters at the conference. The team has different players, fulfilling different roles.
The first task is assembling the team. When FDA comes calling, they will generally come during normal business hours, at least for the first day of the inspection, Beehner said. But they aren’t going to wait around long for you to get the people on site who you’d prefer to participate. As Nancy Schmidt, compliance officer in FDA’s Denver office said in a previous session, “We are there to inspect your firm, not your lawyer.”
“You want to have a tree set up, on who to call,” Beehner said. If the preferred person is unavailable, your SOP should identify the next best and so on.
“Have one person to be liaison with FDA,” she said. That point person will usually be the firm’s quality manager, who will be joined at the hip with the FDA inspector during the inspection process and through whom subsequent communications with the agency will be funneled.
Joining that person on the team is a player who occupies a less glamorous, but critical role: the scribe.
“You want to make sure there is a scribe who is writing down everything that is said and done at that inspection,” Beehner said. The goal, she said, is to avoid surprises during the closing meeting, assuming one takes place, which isn’t always the case, she said.
“Every day at an inspection your team should meet and go through the record of what happened that day,” she said.
“By the time you get to the closing meeting, none of the things they bring up should be a surprise to you if you have keep decent records.”
If a company operates on multiple shifts, that must be taken into account. The first meeting, as mentioned, can usually be expected during business hours. But an inspector has the right to – and likely will – visit the company at other times if appropriate. And it’s unwise to allow an inspector to wander you plant alone, she said.
“If you are operating two or three shifts, you should have a qualified escort for each shift. FDA has authority to inspect EVERYTHING,” she said.
Joining the team in a support role is the ‘back room,’ a designated employee or group of employees who ferret out the many documents that the FDA inspector will want to see: master manufacturing records, batch production records, testing records, training logs.
Fourth quarter crunch time
It all leads up to the closing meeting, Beehner said, where a company has its last chance to make sure it and FDA are on the same page. If you feel as if FDA has made a mistake, or cited something in error, now is the time to bring it up.
“The closing meeting is to ensure your interpretation and FDA’s agree. If there’s a problem, you can say, ‘We are politely going to disagree with you on this and we are going to supply information to support our position,’ ” Beehner said.
“Remember, you are not always wrong. A lot of times FDA is wrong you and can win some of these battles. And we have. You can fight back with factual responses and with data,” David Hinton, CEO of Massachusetts-based herbal remedy manufacturer Nelson Bach, said at an earlier session.