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April 15, 2003 | The head of the Center for Drug Evaluation and Research discusses why the FDA is now kinder and gentler about Part 11 compliance.

Last month the FDA announced it wouldn't cite companies for noncompliance with CFR Part 11 — until, that is, it decides whether to amend or create new guidance on what's covered by Part 11. In an interview with Bio·IT World, the director of the Center for Drug Evaluation and Research (CDER), Janet Woodcock, explained the reasoning behind the FDA's policy shift and what this change means for biotech and biopharmaceutical firms in 2003.

Q| Many people thought that, after six years of CFR Part 11 being on the books, the FDA's patience with noncompliant companies would be wearing thin. Now the agency plans new guidance on Part 11. Could you describe the reasoning behind the shift from enforcement to what you've described as a "narrowing of focus" and an "increase in guidance"?
A| The original intent of the rule was to facilitate introduction of electronic technology to the process of FDA submissions, as well as in manufacturing and production. Part 11 was created to give common-sense guidelines on how to do in the electronic world what was previously done on paper. In the last five years, however, confusion over what's included in the regulation and how to enforce it was impeding the introduction of new technology. The rule had created the exact opposite of what was intended.

We are offering draft guidance now that narrows Part 11's focus. For instance, many businesses misinterpreted the rule, thinking it applied anytime a computer is used. The confusion created by the rule was understandable. Companies didn't know what was covered under Part 11 regulations, and, as a result, they never knew when the other shoe would drop.

What other policy changes, if any, do you see happening within CDER this year?
We'll be working to finalize the guidance we've just completed in draft form, and we will likely have a public meeting later this year, probably in the fall, to decide whether to revise the CFR Part 11 regulation itself.

Some industry observers have speculated that Part 11 will, in effect, "disappear" as a serious regulation. What's your reaction to that?
It's clear we need a rule on electronic records. But we need to clarify the scope of our record-keeping requirements. The regulation won't go away. However, while we won't rescind it, we may revise it. Businesses need direction on how to reliably, safely send documentation to the FDA. They also need more direction on how to maintain that documentation electronically. We just don't want the guidance to be as complicated as it has been.

What specific tools are being used to prod companies that lag in complying with the basic security rules in Part 11?
In the draft guidance, we clearly state that companies must comply with underlying current good manufacturing practices (cGMP) regulations already in place, or those companies may be cited. In other words, cGMP regulations state that a business' equipment must do what it's intended to do. For instance, computer-operated systems should not transform the data they collect in any way that was not intended. That means if you collect data, you must ensure the data [aren't] corrupted or transformed and the results you provide accurately reflect the data collected.

As for audit trails, we'll reissue guidance on what's covered at a later date. Meanwhile, we won't be citing any businesses for what's lacking there.

How will the policy changes regarding Part 11 affect the new-drug approval process?
We want to clarify the scope of our record-keeping requirements to encourage, not discourage, companies to move toward filing forms and documents for the FDA electronically. In that vein, there will be no increasing requirements on these companies.

We also want to facilitate earlier resolution to disputes that arise after inspections for cGMP compliance. Our goal is to prioritize risk — to ensure with our limited inspectional resources that we have the greatest impact on improving the quality and safety of food and drug development.

We've identified three high-risk areas that require the closest scrutiny: sterile drug manufacturing; prescription drug manufacturing; and new registrants previously not inspected by the FDA. Our goal is to prioritize those sites and inspections based on the greatest risks for noncompliance.

Ultimately, these changes are all about getting it right the first time, reducing recalls, and focusing on areas that produce the greatest risk to public health and safety. The agency's approach now is based on the need to do more with our limited resources to improve or streamline drug development and manufacturing processes.

Back to Easing the Pain of Part 11 

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