GMP Tips - Being Prepared for FDA Inspections: More Important then Ever – August 8, 2006

What effect will the politics looming over the confirmation of the next FDA Commissioner have on the rank and file FDA employees? Think about it. Since January of 2001, a period of 67 months, FDA has been led by two Commissioners for a total of 18 months (Mark McClellan for 16 months and Lester Crawford for 2 months and two weeks). The remaining 51 months FDA has been led by Acting Commissioners (Lester Crawford and now Andrew von Eschenbach).

With the controversies FDA has found itself in with Vioxx and other drug withdrawals and black box warning approvals, the contaminated flu vaccine from 2004, and now the politics raging around the Plan B contraceptive, FDA’s leadership has come under a lot of fire. The heat is turned way up!

Might we expect those folks working for FDA that conduct plant inspections to be a little more thorough in their inspections? Not be willing to grant the benefit of the doubt to those undergoing scrutiny?

Any organization undergoing stress at the top is bound to have trickle down effects. There can be no clear direction or mandates from above when top management is under fire themselves. And even if new mandates are given, who’s to say when a new Commissioner may appear on the scene and change things.

There’s no doubt that the troubles FDA finds itself in will affect different employees differently, but one thing is certain, they will all be affected.

Training Tip

Be prepared. Make sure your GMP training is up to date. Make sure the review of your SOPs is current. This is a good time to schedule an internal audit. Find out if there are gaps in any of your systems, then put a program in place to address those gaps. Don’t let the FDA inspection team be your auditors. Stay ahead of the curve. This is the time to be proactive.

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