Keynote Session Highlights Importance of Process Validation and Data Integrity (INTERPHEX 2024)

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Among a list of top 10 commonly seen observations during FDA inspections is the question of process validation, said Daniel Roberts, senior director of Regulatory Compliance at Sidley Austin, a global law firm, and a former FDA drug investigator. Roberts spoke in a keynote session, “FDA Regulatory Updates—Trends & Insight,” at INTERPHEX in New York City, which is being held on April 16–18, 2024.

“There [are] always [many] things to consider regarding process validation, such as making sure that your process validation is adequate and current,” Roberts said. He explained that sometimes companies with older pharmaceutical manufacturing practices get complacent with their processes, some of which were validated decades ago for a drug product that has long been on the market. However, he noted that it is important for companies to keep updated with current good manufacturing practice (CGMP) requirements.

“That is why we say the ‘C’,” Roberts emphasized, urging that companies need to take into account that their manufacturing processes must be compliant with “current” GMPs, rather than just the GMPs under which an older manufacturing process would have been validated.

“Oftentimes there will be changes in plans, and [a company’s] process validation that was done decades ago may not be reflective of [its] current processes,” Roberts said. Thus, it is important to have a process in place where it is periodically evaluated to see if it is still adequate or if it should be revised. “That is a good practice to have and, again, expectations of process validation were different in [for example] 1986 versus 2024, so just making sure that you’re current with regulatory expectations is important [for regulatory inspections].”

Another important point that Roberts made in the keynote was to emphasize the increased focus FDA has on data integrity, particularly the movement toward electronic data. “Maintaining electronic data accuracy is FDA's focus,” he said. Over time, companies are moving away from paper and more towards electronic data, and because of that, Roberts stressed that companies must have controls in place for these electronic data. However, he pointed out that data integrity still involves historical data that are on paper records.

Some of the principles of data integrity include making sure that the data are traceable back to the raw data, legible, and contemporaneously recorded. For example, Roberts said, an operator should not be weighing an item and then later recording that information based just on memory. “Making sure that things are getting recorded in a timely manner and that things are original and active kind are a big portion of this [data integrity],” he noted.

“When you submit an application to the agency, and especially when you're talking about pre approval inspections, when FDA's on site doing inspections, [the agency] wants to make sure that the data you submitted is true and accurate and right,” Roberts explained.