Live Q&A (A5)

In 2019 FDA issued a report on the continuing state of drug shortages and identified three main root causes which included a lack of incentives to produce less profitable drugs, lack of rewards for mature quality systems that focus on continuous improvement and early detection of supply issues and logistical and regulatory challenges that prevent a quick recovery from supply disruptions. In the 2020 Report to Congress, FDA noted that the supply chain was impacted by the pandemic because of a loss of manufacturing capacity and increased demands of many drug products. Often aging facilities lack a mature QMS and adequate physical structures, and manufacturing capacity becomes constrained. However, modernization of aging facilities can pose significant business and regulatory challenges. This session will explore some of the remedies that can be implemented to modernize and improve facilities and avoid drug supply disruptions. Regulatory approaches to facilitate the approval of process improvements and equipment changes post-approval will be discussed. These efforts may be facilitated through the implementation of ICH Q12.