In the pharmaceutical industry, due to all types of business pressures and constraints, it is not atypical for a company to behave reactively and in triage-mode, rather than considering proactive steps that it can take in the compliance arena. In 2005, the Food and Drug Administration (“FDA”) issued three final guidance documents to help focus the industry and encourage companies to consider more thoughtfully and thoroughly the issues of quality risk assessment, minimization, and management collectively.

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