Editor's note: This is the first in a five-part series exploring issues that affect management’s ability to detect the warning signals of current good manufacturing practice (cGMP) compliance problems in the pharmaceutical industry.

Compliance to current good manufacturing practice (cGMP) regulations is a part of normal pharmaceutical business that requires diligent management oversight. As with other business functions, management has the responsibility to ensure that systems are in place to effectively monitor the state of control in order to intervene with timely decisions to manage risk, achieve goals, and add stockholder value.

However, the number of pharmaceutical companies that have received FDA warning letters or that are under consent decrees indicates that management oversight of cGMP compliance is a significant and continuing problem in the industry. There have been tarnished reputations, loss of brand loyalty, stockholder lawsuits, and unprecedented financial impact. At some point, the warning signals were undetected, unheeded, or rationalized away.

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