Rethinking Manufacturing Quality in Pharma

Rubrik: GxP

(Treffer aus pharmind, Nr. 05, Seite 424 (2025))

Helbling J | Bernasconi M | Friedli T

Rethinking Manufacturing Quality in Pharma / Helbling et al. | Manufacturing Quality · Helbling J, Bernasconi M, Friedli T · Universität St.Gallen
Quality Leadership Risk Management Quality Metrics Quality Management Maturity Quality Culture Patients expect to have access to required drugs when needed. However, the SARS-CoV-2 pandemic has made it clear that drug availability is not guaranteed, and that supply chain disruptions and product shortages are a threat to public healthcare [ 1 ]. However, drug shortages are unfortunately not a new topic. Even before the pandemic, the U.S. Food and Drug Administration (FDA) investigated the root causes of the increasing number of drug shortages [ 2 ]. In particular, manufacturing quality issues contributed 62 % of drug shortages from 2013–2017 [ 3 ...