By the time a consent decree comes along—which happens when a firm repeatedly violates current good manufacturing practice (cGMP) requirements and the Food and Drug Administration (FDA) forces it, through legal channels, to make specific changes—it’s no longer a discussion about responses to observations. It’s about a do-it-yourself renovation—a complete makeover. It’s a “gut-it” approach, as never before, which exposes the cracked foundation and termite-eaten beams weakened over time.

This is because the common element of a consent decree is demonstrating sustainability. As in “over time.” That takes more than a fresh coat of paint.

Regardless of the huge effort and expense to redesign and implement a more robust quality management system, the real test comes afterward: sustainability.

Long after the consultants have pulled up their tent stakes, with the project plans flawlessly executed and senior-management dashboards faded away, the real mettle is yet to be tested: sustainability.

“Sustainability” is an attribute that is difficult to achieve under normal circumstances, not to mention under the supervision of the Department of Justice.

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