Health systems are actively working to bolster quality and safety practices in outpatient settings as more care historically only performed in hospitals moves to ambulatory facilities. CMS recently ...

Following the launch of its initiative, "Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach," FDA has been looking to process analytical technology (PAT) for improvements in process ...

Quality is a difficulty term to define, but most people know it when they see it. A quality product is made well, with integrity and attention to detail. A quality management system (QMS) is a formal, ...

Harold Dodge, one of the founders of quality management, changed our view on quality with a vital statement: "You cannot inspect quality into the product." Dr. Deming helped make the quote famous. The ...

After a long wait, the U.S. Food and Drug Administration (FDA) recently published a Final Rule to harmonize the Quality System Regulation (QSR) codified at 21 C.F.R. Part 820 with the internationally ...

Following in the footsteps of the other review programs at the US Food and Drug Administration's (FDA) Office of Pharmaceutical Science, the Office of Biotechnology Products (OBP) is currently in the ...