Effective Strategies for Preparing for FDA Inspections: Planned and Surprise (Full Transcript)

Speaker 1: Keeping our discussion in the sort of prior to the inspection, you know, one of the ways to be successful obviously is planning, right, and planning is critical. But we know there's two types of inspections, right, that the FDA does. There's sort of the general and the pre-approval, right, or more of a planned inspection. As far as more of the surprise inspection or general inspection, can you share with us what we can do to plan or prepare, I guess, because you can't really plan, but maybe preparation is

Speaker 2: a better word. What can we do to prepare? So I always like to be inspection ready, and there are numerous things that we can do, whether it's a pre-approval or for-cause inspection or general GMP inspection. One of the things you can do is have a robust internal audit plan or program, making sure that you understand your own faults, so that anything the FDA or other inspectors may find is not a surprise to you, that you've got corrective actions in place or a plan to fix any problems, because everybody has issues, right, we all have improvements that we can make. So that would be number one. Number two would be having kind of a binder or place where we keep common documents or common things an inspector may look for, and what I'm talking about is like a table of contents for standard operating procedures, an org chart. These common things, we keep them up to date, a list of deviations. These kind of things are items that any inspection is going or inspector is going to look at, maybe our quality manual. If we've done any kind of annual reporting to the FDA, those types of things, keeping them up to date, keeping them available, keeping them in a common place, so when the inspector asks for it, it can be immediately provided and you're not fumbling or having to create the report. Those types of items, it makes you look really organized and really prepared. So it sounds like all of the things

Speaker 1: that you mentioned as it relates to preparation for a surprise inspection would carry over obviously to the scheduled inspection, but is there anything additional perhaps that we can do, like maybe do we move our gap assessment schedule up if we have a planned inspection, right? We have a date on the calendar, would we perhaps perform a mock ahead of that or just ahead of that or making sure we give ourselves remediation? Is there anything additional or is it because certainly you thoroughly covered, you know, being inspection ready all the time,

Speaker 2: right, in that concept. For a planned inspection, I like to reach out to the inspectors. Now, sometimes they're willing to give you this information and sometimes they're not, but I always like to ask what they're going to inspect. You know, can they provide you with an agenda? That allows you to prepare. If it's an FDA pre-approval inspection, you know they're going to be specifically looking at, you know, a range of items. So this specific drug product, so you'll want to prepare everything and anything related to that specific drug product. If it's just a general, maybe a supplier approval audit or something along those lines, again, reaching out, getting an audit agenda, and then collecting as much documentation surrounding what you do for that client or for, you know, maybe if you do FDA things and other items that are not related to the FDA, focusing on that FDA documentation. We expect them to look at, if we've had pre-previous inspections, what kind of CAPAs did you put in place? What kind of corrections did you make? You know, gathering that information and putting it together. So there are definitely ways to prepare.