PAREXEL's QbD approaches can help pharma companies maximize product quality, safety

PAREXEL International Corporation (NASDAQ: PRXL), a leading global biopharmaceutical services provider, and the Parenteral Drug Association (PDA) today announced the publication of Quality by Design: Putting Theory into Practice, written to help companies maximize product quality and safety. As increasing regulatory pressure is being placed on biopharmaceutical companies to be accountable for Quality Systems, the book serves as a definitive source on the interpretation and implementation of Quality by Design (QbD) approaches.  The book features chapters by Lead Author and Editor Siegfried Schmitt Ph.D., Principal Consultant, PAREXEL, as well as other leading experts from the biopharmaceutical industry.

Quality by Design: Putting Theory into Practice addresses not only how compliance can be achieved, maintained and improved but also how it can result in positive financial impact, including reducing the cost of product development. The book outlines key benefits of QbD implementation, including reducing or eliminating the number of reworked batches and drastically reducing product recalls, as well as achieving better manufacturing practices and more robust processes.

"The contributors to this important resource are focused on helping to propel the industry in improving healthcare savings, safety and innovation, while simultaneously providing maximum assurance of product quality. Successful implementation of QbD has the potential to help companies achieve industry leadership," said Dr. Schmitt. "QbD applied in conjunction with a risk-based compliance approach will deliver cost savings across the lifecycle of a product. The collective expertise of the international group of subject matter experts represented in the Quality by Design compilation offers invaluable information to guide biopharmaceutical companies in emerging regulatory requirements.  The book describes how a new level of value can be derived from process understanding and knowledge acquisition in development and manufacturing."