FDA drafts kinder, gentler record-keeping guidelines

By Mark A. DeSorbo

ROCKVILLE, Md.—When the Food and Drug Administration (FDA) yanked its proposed guidance on electronic record keeping, many thought their prayers had been answered. While that thrill was short-lived, all walks of the life sciences will have much to celebrate if and when a kinder, gentler CFR 21 Part 11 comes to pass.

The new draft is a back-to-basics approach, using record-keeping regulations outlined in existing predicate rules of the Food, Drug and Cosmetic Act. This is a far cry from a previous proposal calling for electronic data on anything that had to do with quality, process or environmental monitoring—which, from a cleanroom standpoint, meant an enormous amount of information to compile, prioritize and maintain.

“We're trying to limit the scope of Part 11 over the records that a company keeps,” said Joseph Famulare, director of manufacturing and product quality for the Center for Drug Evaluation and Research (CDER), during a recent Webcast featuring several agency and industry officials.

The FDA's recent draft scope, he said, means drug, medical device and biotech firms will have to look at the predicate rules to see what applies to specific manufacturing applications.

“Once you have determined what the predicate rules are, that is the scope of the records that are required to be held,” Famulare adds. “If those records aren't required by the predicate rules…end your Part 11 approach.”

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For records and submissions to the FDA, Famulare says firms need to take a risk-based approach: “Look at the criticality of the records and then you can use judgment as to the importance of controls that you need to apply.” Prior FDA guidance on CFR 21 Part 11 divided life science industries. Some manufacturers dug deep to ensure compliance, while others gambled and complied only after being cited, says Bruce Klopfenstein, a consultant at Theoris, Inc.—an FDA compliance service agency.

“The FDA was really putting a burden on the industry, and it would have cost companies billions to comply,” Klopfenstein says.

And that sentiment is clear in a CleanRooms QuickVote poll (right), which asked: “Which area of your pharmaceutical manufacturing facility would pose the greatest vulnerability if the FDA should show up for a surprise inspection?” Forty-four percent indicated that record, documents and change controls (CFR 21 Part 11) were the greatest vulnerability, while 13 percent said corrective/preventive actions was the weakest area. Another 13 percent pointed to equipment controls, while 12 percent said they were hurting in design control.

But now, Klopfenstein says, “It is no longer that just because it was on a computer it falls under Part 11. You have to look at the predicate rules and see how you're using the record. It's a very reasonable regulation.”

And that's what the FDA is aiming for, says Alan Goldhammer, associate vice president of the Pharmaceutical Research and Manufacturers Association (PhARMA; Washington, D.C.). Thirty or 40 years ago, he points out, drug manufacturers would have a pH meter, with someone manually taking readings. Now, the process is automated, with more frequent sampling.

“Do we need to keep data points for every tenth of a second, or do we need to keep a printout that shows the pH throughout the whole process?” Goldhammer adds. “This is the kind of flexibility that we need to move toward.”


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