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Quality by Design: Transforming 21st Century Pharmaceutical Manufacturing

Thought Leadership

As published in Pharma's Almanac Q3 2016

The quality of pharmaceutical products is the top priority for both drug makers and regulators. To ensure consistent high product quality and improve the efficiency of manufacturing and regulation, the FDA introduced quality by design (QbD) to the pharmaceutical industry in its 2002 Pharmaceutical cGMP initiative, “Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach.”1

The QbD concept has been widely adopted as a standard of practice for manufacturers, including those in the automotive, semiconductor, electronics and chemical processing industries. Regulators have also embraced QbD as a means to modernize the regulation of pharmaceutical manufacturing and product quality through manufacturing science, based on methodologies proven across countless applications. From their standpoint, QbD-based processes hold great potential in creating the efficient, agile and flexible manufacturing systems required by biopharma to reliably deliver safe, effective high-quality drug products to patients in a secure supply chain.