For decades, pharmaceutical and veterinary manufacturers have relied on Good Manufacturing Practices (GMP) set out in Eudralex, in particular Volume 4, to guide them on implementing safety and quality standards that determine how medicinal products are produced, documented and released. As the go-to guide for everything from quality control to training personnel, self-inspection and beyond, pioneering GMP standards for both human and veterinary products, Eudralex Volume 4 has managed to provide the two industries with a unified, reliable and consistent regulatory framework over the years. Although the framework has undergone notable changes throughout its existence, its familiar layout and scope have, for the most part, remained untouched even after several annexes were added.