Quality & Compliance
The Key to a Stable Supply of Medicines
The COVID-19 pandemic revealed a structural weakness in many products' supply chains. In terms of supply of pharmaceutical products, supply shocks were not mitigated when intermediates or production...
Implementing a Risk-Based Supplier Management Program
According to recent FDA updates on the implementation of the Safety and Innovation Act (FDASIA), nearly 40 percent of finished drugs are being imported, and nearly 80 percent of active ingredients,...
5 Steps for Developing and Managing Supplier Quality Programs
With the increased pressures of cost control for manufacturers of FDA-regulated products and the rapid expansion of globalization of the supply chain, the expectations of manufacturers and sponsors...