Over the years, there have been major changes in pharmaceutical manufacturing that have affected the FDA’s
regulatory approach to product quality. These changes include: increased number of pharmaceutical products and
a greater role of medicines in health care; decreased frequency of FDA manufacturing inspections because of fewer
resources available; advances in pharmaceutical sciences and manufacturing technologies; and globalization of the
pharmaceutical industry.
The overall impact of these changes warranted a systematic reappraisal of FDA’s approach to product
quality regulations.
