Just when you think that the Food and Drug Administration (FDA) has to stick to the script by quoting chapter and verse of current Good Manufacturing Practices (CGMPs), it gets very progressive and offers straight talk about corporate commitment and leadership.

I have reported before that the FDA expects corporate oversight of the quality management system. The Johnson & Johnson debacle is just one recent example where the FDA cited the corporate folks for taking their eyes off McNeil, where Tylenol is manufactured.

But the Warning Letter to PolyCarbon Industries recently posted on the FDA website has an added dimension—a call for commitment and leadership. The Warning Letter, dated Dec. 2, 2010, reads as follows:

“It is essential that your firm establish and maintain a corporate commitment to an effective pharmaceutical quality system. Your firm’s management should demonstrate leadership and ultimate responsibility by participating in the design, implementation, and monitoring for quality throughout the company.

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