In the pharmaceutical industry, quality by design (QbD) has long been applied to manufacturing. Incorporating good manufacturing practices (GMP) into the production process is expected and required by the Food and Drug Administration (FDA). Yet, rarely are QbD practices adopted … Continue reading →

Today’s clinical trials require quality oversight for one simple reason: sponsors are ultimately responsible for the integrity of the data generated by their third-party vendors. This is most evident in recent FDA warning letters issued to top-quality pharmaceutical firms for … Continue reading →

“Third-party quality oversight: designing an optimal programme” was published in the August 2011 issue of Scrip Regulatory Affairs (see www.scripregulatoryaffairs.com).

Quality oversight of clinical trials gains traction as sponsors are held accountable by the FDA  NORFOLK, Va., July 20, 2011—Clinical research organization (CRO) Beaufort, LLC, has added quality oversight to its services for clients in the pharmaceutical, diagnostics, and medical … Continue reading →