The FDA Office of Pharmaceutical Quality has published its annual report for 2021. What does the report say on its eleven pages?
In the beginning the report describes the “mission” of the Office of Pharmaceutical Quality (OPQ). The OPQ’s mission is to ensure that quality medicines are available to the American population. Access to quality medicines was also the focus of the White House 100 Day Report. The White House report recommended strategies for supply chain transparency and resilience. Among other things, however, the White House report also recommended introducing an evaluation system to assess the robustness of quality management systems in pharmaceutical production facilities. The OPQ is currently working on this. The goal is to show the companies that quality management systems do not only include simple compliance with GMP rules, but go beyond that. Currently, a pilot programme is still underway with foreign companies to assess their Quality Management Maturity (QMM) ratings.
Refference: www.gmp-compliance.org
