FDA Office of Pharmaceutical Quality outlines goals
FDA’s Office of Pharmaceutical Quality (OPQ) released a white paper detailing its objectives for improving quality oversight and how it intends to achieve them. The super-office at the Center for Drug Evaluation and Research (CDER) was formed in 2015 and is responsible for pharmaceutical quality regulation, including submission review, manufacturing facility assessment and quality surveillance (see BioCentury Extra, Jan. 12, 2015).
The office intends to develop quantitative risk assessment tools which will form the bases of its internal and external communications. The assessments will focus on identifying consumer risks and product failure modes specific to relevant patient populations by drawing on standardized data submissions from companies. FDA also plans to collect data on currently used quality control metrics to improve surveillance of product and facility quality and inform risk-based inspection planning. Additionally, the agency plans to streamline inspection reports so that they can be incorporated into mobile technology...