The Food and Drug Administration (FDA) announced a new initiative in August to enhance the regulation of pharmaceutical manufacturing and product quality.
The initiative focuses on the FDA’s Current Good Manufacturing Practice (CGMP) program and will cover veterinary and human drugs, including human biological drug products such as vaccines. It seeks to integrate quality systems and risk-management approaches into the existing programs and encourages adoption of modern and innovative manufacturing technology.
The initiative also is intended to enhance the integration of preapproval review with CGMP programs and achieve more consistent application across agency organizational components. In addition, the initiative will use existing and emerging science and analysis to ensure that limited resources are best targeted to address important quality issues, especially those associated with predicted or identifiable health risks.
The Pharmaceutical Research and Manufacturers of America, the industry’s trade group, applauded the announcement, saying it will "help ensure that patients continue to benefit from timely access to high-quality pharmaceutical products manufactured according to state-of-the-art, science-based standards." Critics, however, wondered whether FDA was loosening some standards simply because it has run out of money to inspect medical factories frequently.
For more information about the initiative, see www.fda.gov/bbs/topics/news/2002/new00829.html.
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