Bites of Bitter PAI - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

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.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
32%
Breakthrough designations
8%
Protecting the supply chain
40%
Expedited reviews of drug submissions
8%
More stakeholder involvement
12%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
Source: Pharmaceutical Technology,
Click here