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By Rachael Roehrig

RachaelRoehrigOverseeing the quality of the world’s drug supply requires unrelenting vigilance. It’s an issue that concerns everyone in the pharmaceutical realm: regulators, standard setting organizations, industry, and academia. Some recent areas of concern to both the FDA and the pharmaceutical industry include:

  • Risk Management—in what ways can risk management be used to offer a comprehensive assessment of risk both over the entire manufacturing network as well as over the product lifecyle;
  • Performance-based quality assessments—implementation of performance-based quality assessments can help ensure that drugs available to patients are safe and effective and that high standards remains static throughout batch production and lifecycle;
  • Innovative manufacturing and regulatory assessment—developing and implementing rigorous, process-wide standards to avoid biological contamination can be accomplished through innovative manufacturing and regulatory assessment such as incorporating new technologies, equipment, and control systems; and
  • Biosimilar biological drug products—explore the new paradigm of biosimilars to reveal what is needed to cross the finish line to approving these drugs.

The never-ending quest for product quality creates angst for everyone involved in the development of drug products and in paying the high cost to solve very fundamental and important issues. FDA is working to both gather information on to how to make the achievement of quality more seamless and on other new quality-based initiatives.

In mid-September, FDA and the Product Quality Research Institute (PQRI) will be hosting the FDA/PQRI Conference on Evolving Product Quality, where high-level FDA representatives will discuss future plans for improving overall drug product quality and patient safety using new risk management techniques and quality metrics.

This meeting will provide an interactive forum for FDA and other international regulatory agencies to discuss ideas on addressing issues affecting global pharmaceutical efforts.

For more information on these topics and to see the program agenda for this conference, click here to view the preliminary program.

Rachael Roehrig, Ph.D., works at 3D Communications, where she uses her extensive scientific and regulatory experience, as well as technical writing skills, to prepare clients for successful regulatory interactions and FDA advisory committee meetings. Roehrig currently serves as the chair for the Product Quality Research Institute (PQRI) and sits on the Board. She received her doctorate in chemistry from The Johns Hopkins University, where she studied photophysical inorganic chemistry applied to molecular cardiobiology