MedCon: FDA official offer tips on verifying, validating manufacturing processes

COLUMBUS, OH – It isn’t always clear when to choose to verify or validate manufacturing processes. But experts from the US Food and Drug Administration (FDA) recently offered some tips for helping to make sense of the decision.

“I wish that I could tell you that there’s always going to be a right or wrong answer and that 100% black and white, and you can make that determination. It isn’t that easy, and I know that,” Michelle Glembin, medical device senior operations officer in the Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Office of Inspections and Investigations (OII) at FDA, said at the 2026 MedCon conference, sponsored by the AFDO/RAPS Healthcare Products Collaborative.

Verification is defined as confirmation through objective evidence of the fulfillment of specified requirements. Validation also uses objective evidence, but concerns fulfilling requirements for a specific intended use or application. The key phrase in both definitions is “objective evidence,” Glembin said.

Put another way, verification is an option when an output can be fully inspected and/or tested, whereas validation occurs when an output can’t be fully inspected and/or tested without destruction or use, she noted.

The Quality Management System Regulation (QMSR) states that processes should be validated if their outputs cannot be verified with monitoring and measurement and deficiencies appear when the product or service is being used.

“[Y]ou have to be able to provide objective evidence that your device is going to meet the intended use and is not going to fail when it gets in the field,” Glembin explained. “It has to demonstrate validation, must demonstrate the ability of these processes to achieve planned results consistently. Not one and done, but consistently, so no matter what device is being used by whoever, it will always perform as intended.”

Considering verification or validation

One consideration for when to verify or validate is the risk for the patient or the user in the event of a process failure. Validation is more likely as this risk increases, while verification may be the most appropriate method with a lower risk process.

Validation is always required for processes with destructive testing, but verification may be possible with non-destructive testing. Complex processes are also more likely to require validation, while more simple processes could be verified when combined with process monitoring.

The critical quality attributes of a process play a role as well. “You must identify the critical quality attributes that the process must achieve based on your device design requirement, not just the attributes that are easy to measure,” Glembin said. “We’re not going to let you get away with it that quickly or that easily. Focusing on the wrong output can lead to choosing verification when validation is actually required.”

Verification may also be appropriate in scenarios where defects can be “reliably detected during testing,” whereas validation is necessary when available test methods do not identify critical defects.

“It really it comes down to, ‘it depends,’ and you're going to have to be able to justify why you did one over the other,” Glembin said. “It may be okay, it may not be, but that’s a discussion you'll have with the investigator when they're doing your inspection.”

Glembin explained that manufacturers need to consider whether it is practical to have verification during routine production. If verification is possible and is implemented, then it may be accepted when viewed together with other factors. However, if you do not choose verification, validation is still required, she noted.

“I stress, you must have objective evidence to prove to us that you met your design requirement and your verification and validation requirement,” Glembin said.

Manufacturers should use critical thinking to evaluate whether to verify or validate a process.  “Make your decisions and document your rationale. It doesn't mean that FDA will 100% agree with you, but it will allow that discussion and that dialogue to occur,” Glembin said.

FDA may be conducting an inspection years after the decision to verify or validate has been made, and the documentation needs to be there. “When we’re looking at it, you're not going to remember what your decision was and why you did what you did,” she said. “Not only that, the people that were involved in that decision-making at the time may not be there anymore.”

The decision to verify or validate is not set in stone, Glembin noted. The action should be taken quickly, monitoring and measurement should occur, and if problems with control develop after a decision to verify, manufacturers can update their decision.

“[P]eople sometimes mistakenly think they can't go back and make a different decision after they've already made one. That is not true,” she said.

At the center of all decision-making should be the patient and/or the user of the process. The risk should be judged based on the “probability of occurrence of harm and severity of that harm,” Glembin noted.

“Always, always, always think about what could go wrong and what would be the harm to the patient and or user,” she said.

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