NMPA holds training on internal review of vaccine regulatory quality management system
The National Medical Products Administration (NMPA) held a training on the internal review of vaccine regulatory quality management system in Beijing from Sept 18 to 19 to cultivate more internal review professionals.
Internal review is an important measure of evaluating the effectiveness of the quality management system and promoting its continuous improvement. Since 2020, the NMPA has conducted internal reviews on a yearly basis to detect problems, identify and control risks, and carry out inspections and rectifications, which has played an important role in promoting the continuous improvement of the national vaccine regulatory system.
The training aimed to cultivate backup internal reviewers for the vaccine regulatory system, accelerate the overall development of the drug regulatory quality management system, strengthen the awareness of quality, promote the integration of quality management into daily work, and improve the standardization of drug regulation.
It invited experts in standards of quality management systems to provide detailed lectures on the emergence and development of the ISO 9000 family of standards. Explanations of specific GB/T 19001-2016 standard clauses were also given based on the Global Benchmarking Tool used by the World Health Organization for evaluation of national regulatory authority for medical products and the NMPA’s vaccine regulatory quality management system.
More than 60 officials from the NMPA and related affiliated institutions participated in the training.