Supply Chain Management and Product Quality

Adulterated and substandard drugs are a growing public health risk. While manufacturers struggle to maintain quality standards within their organizations, regulators are extending their attention to include the entire supply chain, from API producers to distributors, wholesalers, warehouse operators and agents. The broadest responsibilities, however, are reserved for brand owners of pharmaceutical products, who are ultimately responsible for any quality failure that occurs anywhere in their supply chains.

Pharmaceutical companies face new regulations, such as the European Union’s Falsified Medicines Act, which imposes on them responsibilities for the cGMP compliance of their suppliers. They also face greater inspection pressure from the FDA and their counterparts around the world. Regulators are combining their limited resources and sharing a broad range of information in a powerful, global initiative to maximize the number of inspections they conduct and the violations they find.

UL works with many of the world’s leading pharmaceutical companies. We assist our clients in achieving and maintaining cGMP compliance within their organizations and throughout their supply chains. Among the capabilities on which our clients rely are:

  • Online training curricula that is authored or reviewed by the FDA as part of its unique collaborative agreement with UL, is available to clients to help them address the full range of cGMP training needs;
  • Customized, company-specific training, both online and instructor-led, to address knowledge needs or gaps linked to individual suppliers, production lines, facilities or departments;
  • Extension of training to suppliers with full validation, testing, automatic generation of remedial training when needed, and documentation I audit-ready format;
  • Generation, distribution and documentation of compliance-mandated communications between the brand owner and suppliers;
  • A versatile, robust Learning Management System that is easily linked to the company’s document management system for expanded utility in identifying, tracking, mitigating and documenting supplier activities, intake procedures and contract conditions;
  • Mobile applications tailored to company-specific needs including training, regulatory updates, SOP changes, information exchanges among dispersed operations and suppliers, and compliance-required communications.

Global Regulatory Compliance Learning

Addressing International Regulatory and Corporate Compliance Requirements