ISPE Readiness Report Bundle
Report on ISPE Work to Support Establishment of the European Union Health Emergency Preparedness and Response Authority (HERA)
Published: May 2023
Pages: 42
Special Pricing for Emerging Economies
The ISPE Baseline Guide: OSD Forms is intended to offer a tool for consistent framework for regulatory interpretation, while still allowing a flexible, innovative, and compliant approach to facility design, construction, commissioning, and qualification. This approach is intended to allow manufacturers to better serve their customers by helping reduce costs and improve product quality.
Increasing Domestic Resiliency in the Supply of Essential Active Pharmaceutical Ingredients
Published: December 2020
Pages: 24
Special Pricing for Emerging Economies
ISPE produced this report in response to a request from the US Department of Air Force Acquisition COVID-19 Task Force (DAF ACT) to advise regulatory, technical, and workforce elements favorable to creating a more robust and sustainable domestic pharmaceutical manufacturing base for Active Pharmaceutical Ingredients (APIs). 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 at any time, but particularly in pandemics and other emergencies.
ISPE has bundled these reports in keeping with its vision and mission and to provide solutions to complex pharmaceutical industry challenges and enhance efforts to develop, manufacture and reliably deliver quality medicines to patients. Together the reports reflect ISPE’s commitment to provide guidance on the supply of medicines to the people of every nation.