Bites of Bitter PAI - Pharmaceutical Technology

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Bites of Bitter PAI

Pharmaceutical Technology
Volume 29, Issue 11

More failed PAIs

"Can you believe it?" our GMP Agent-in-Place sputters. "We failed two PAIs for this oral capsule product!"

"It was during the early days of the FDA's PAI program, and none of us knew what was coming, so we did the usual thing, filing the NDA based on research and small scale data.

"Obviously, one of the prime PAI criteria is that the site be capable of production. But the FDA showed up right after our filing went in, and we had torn up the manufacturing area to upgrade the utilities and install the necessary new equipment.

"So I meet the inspectors at the door, tell them we're not ready for an inspection, and turn them around.

"Of course, they issued a formal withhold approval. Later, during the second PAI, the inspector didn't like our justification for changing our granulation drying step from tray-in-oven to a fluid-bed dryer. We argued that this was a call for the reviewing chemist, but the inspector was adamant, saying 'You can get the chemist to overrule me then.' We knew that would never happen, and it didn't. So we received another withhold approval.

"The good news," sighs our hard-pressed Agent, "is that six months and one new bioavailability study later, the NDA was approved."

Pharmaceutical Technology's new monthly "Agent-in-Place" column distills true-life cautionary tales from the secret files of Control, a senior compliance officer. If you have story of clueless operators, oblivious management, inopportune lapses of judgment, or Murphy's Law in action, please send it to Control at
We won't use any names, but if we do use your tale of disaster, courage, or just plain weirdness, Control will send you a coveted Pharmaceutical Technology t-shirt.


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