How Excipient Supplier Certification Helps Pharmaceutical Supply Chain in Europe

In Europe, the Falsified Medicines Directive (FMD) and the changes to EU Part 1 GMP Section 5 have been designed to improve product quality entering the supply chain by placing new and more detailed requirements on the qualification and supervision expected of pharmaceutical excipient manufacturers and distributors. This includes the expectation that there will be a risk-based approach to defining the excipient GMPs and more demands on distributors via GDP. These new regulatory requirements have taken more than a decade to evolve following regulatory false starts and evidence of deliberately adulterated excipients in medicines, exposing patients to harm.