“We truly appreciate the opportunity to contribute to the DAF ACT Team,” ISPE President Thomas Hartman said
The ISPE has announced its participation in the Department of the Air Force Acquisition COVID-19 Task Force (DAF ACT) to advise regulatory, technical, and workforce element, with the aim of creating a robust and domestic manufacturing base for APIs in the US.
Finished pharmaceutical products are manufactured using globally secured APIs, however during the COVID-19 crisis, border closures and other logistical challenges revealed supply chain vulnerabilities threatening the global supply and availability of APIs and putting patients at risk in those countries unable to secure supply.
The ISPE was invited to advise the task force on opportunities to restore a robust and sustainable manufacturing base for critical medicines in the US. The findings identified in the report are said to be applicable worldwide as nations look for opportunities to ensure a reliable supply of critical medicines for their patient populations.
“The objective of this partnership aligns with ISPE’s mission to support the international pharmaceutical industry and multiple programs we actively lead, which includes the drug shortages initiative, advancing pharmaceutical quality (APQ), continuous manufacturing, and regulatory quality harmonization (RQHC)," said Thomas Hartman, ISPE President and CEO. “We truly appreciate the opportunity to contribute to the DAF ACT Team and look forward to the successful outcome of this program.”
Under this partnership, ISPE assembled a task team of subject matter experts with in-depth knowledge in engineering, manufacturing, regulatory and compliance, environmental health & safety, analytical, and supply chain management. ISPE addressed challenges in these areas in the report: “Increasing Domestic Resiliency in the Supply of Essential Active Pharmaceutical Ingredients”.
Published in December 2020, the report lays out technical, regulatory, and workforce changes that stakeholders in any country or region could consider to reduce the risks of API shortages to meet demands for essential medicines.