The presentation was delivered by Diane Hustead, Chair of the ISPE Drug Shortages Initiative. Hustead highlighted ISPE’s global expertise and longstanding commitment to drug shortage prevention, publications, recent activities, and near-term priorities. She emphasized that the industry is in a transformational period for product-availability risk management, or shortage prevention planning, and that many global harmonization opportunities exist, as identified in the team’s recent article, “Drug Shortages Global Convergence Opportunities,” published in the September/October issue of Pharmceutical Engineering. The SPOC Working Party is composed of single points of contact for medicines shortages from the national competent authorities of EU Member States responsible for human and veterinary medicines. The Working Party is responsible for monitoring events that could lead to public health emergencies impacting the supply of human medicines in the EU and reporting them to the EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products. Additionally, the Working Party drafts specific critical medicines lists for major events and public health emergencies, tracks demand and stock levels of these medicines, and reports shortages (along with potential alternatives) to the EMA.
Quality Management Maturity Industry Study
ISPE is partnering with the University of St.Gallen, Switzerland, to conduct an industry study on International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) “ICH Harmonized Tripartite Guideline Q10: Pharmaceutical Quality System” maturity and quality practices, including culture. The study is based on the ISPE Advancing Pharmaceutical Quality™ (APQ) Program with St.Gallen pre- and post-assessments.
ISPE’s APQ program is an industry-led quality management maturity assessment and benchmarking initiative that offers a practical set of tools and systematic approaches to help organizations enhance the effectiveness of their pharmaceutical quality systems. The program is aligned with international initiatives that promote quality excellence, as well as with the US Food and Drug Administration (FDA)’s focus on quality management maturity and rating the maturity of manufacturing facilities. Study participants will receive individualized analytical reporting benchmarked against industry. For more information, or to enroll, contact matteo.bernasconi@unisg.ch.
Regulatory Digest
