FDA officials: Consider a master validation plan for process validation during inspections

COLUMBUS, OH – Having a master validation plan in place will help inspectors identify validated and verified activities during an inspection at your company, according to US Food and Drug Administration (FDA) officials.

It is an “umbrella-type issue” that many firms “don't really know what processes they do validate,” Laureen Geniusz, consumer safety officer in the Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA) at FDA, told attendees during the 2024 MedCon conference, sponsored by the AFDO/RAPS Healthcare Products Collaborative and FDA.

Although FDA inspectors won’t talk about process validation during every inspection, it very well may come up, she noted. The most common reasons to ask about process validation would be as part of a Corrective and Preventive Actions (CAPA) activity or design discussion.

“[B]ut sometimes we just come in and just say, ‘All right, what processes do you validate, or do you verify?’ she said. “When I'm in a room with the firm, and they pause a little bit and think about that, then I get a little concerned.”

A master validation plan is not a requirement, but it is “really, really important and helpful,” Geniusz said, helping FDA inspectors see validated and verified activities as well as installation qualification, operational qualification, and performance qualification (IQ/OQ/PQ) protocols. It is “kind of a starting point to look at and to understand what you do,” she noted, which also includes outlines for review monitoring validation and changes that may affect validation.

“We’re investigators who don't have a lot of time to be at your firm. We don't want to camp out there. You don’t want us camping out there,” Geniusz said. A master validation plan is “something that I'm kind of surprised that I don't see every company having, but it’s [an] extremely useful document.”

Phil Pontikos, investigator and medical device national expert with the division of medical products and tobacco program operations branch in ORA at FDA, told attendees another benefit of a master validation plan is retention of historical knowledge within a company, especially as a firm considers mergers and acquisitions or downsizing. “There's another angle where that value is there, so that you can have transparency and understand the systems that are in place,” he said.

Benjamin Dastoli, consumer safety officer within OMDRHO at FDA, said he walks through a facility early in the inspection when considering process validation and verification. “I want to see the whole flow, he said. “What I’m doing during that walkthrough is I’m taking a mental note of the different equipment that I see and trying to understand [whether] something that would be validated or verified.”

He encouraged attendees who are associated with quality management to do the same walk, “because you'd be surprised how many times this whole process was missed, because the quality person didn't even realize that that was really something they were doing on the floor during manufacturing,” Dastoli said. “If you're a quality manager, just make sure you understand all the processes going on.”

Thomas Peter, medical device senior operations officer at OMDRHO, said having a systematic approach to identifying processes in a facility can help identify things that get overlooked. One example of an overlooked aspect of process validation is test methods.

“Even if a process is something that is fully verifiable, may not need to be validated, the method by which you are performing that verification may need to be validated,” he said. “As you're going through and listing all of your processes, a master validation plan or whatever you want to call it, these are the types of processes we need to be thinking about when determining whether to validate or verify.”

Validated and verified processes

A major issue Peter sees during inspections is when a company trying to identify what processes needs validation or to be fully verified, and is making the wrong decisions, which is “usually because we’re looking at the wrong output of the process.”

“If you think about what the regulation says, validation is required where the output cannot be fully verified, so knowing what output you’re interested in is critical,” he said.

He sees this issue occur most often with soldering, giving an example of a company incorrectly assuming that soldering does not need to be validated because it is fully verifiable through testing a device for electrical continuity. “If you look at electrical continuity as that output that you’re interested in, maybe you can come to that conclusion, but that is typically the wrong output because it doesn't consider reliability aspects of the solder joint,” he said.

“Depending on the intended use of the device or the use environment, we might need to worry about things like vibration, thermal cycling, humidity, corrosion—all these things that can cause solder joints to fail sometime down the road,” he continued. “Even though you’re passing electrical continuity in-house, you’re having field failures, and so these are the outputs you need to be considering when determining whether or not to validate.”

Often, that decision comes back to the design of the device. An FDA inspector in that situation might ask for the company’s reliability requirements established in design “because this becomes your acceptance criteria and validation,” Peter said. “It ties back to design and risk management as it usually does.”

Companies that say a process is fully verifiable will be asked to justify that claim, Geniusz added.

“Can you prove or explain why you think it’s only 100% verifiable and not a validated process?” she asked. “There are for sure processes that can be just verified. We’re not trying to say you can’t ever do 100% verification, but be aware that we're going to ask, why are you doing this and why do you feel that's sufficient?”

FDA officials: Consider a master validation plan for process validation during inspections

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