Eu Gmp Annex 13

Get to know more about the scope and limits of complex regulatory guidelines! PharmAudio audiobook Understanding Pharma Guidelines EU GMP ANNEX 13 Investigational Medicinal Products Complexity Meets Reality Read by Alison Rippier, Dr Joseph Rippier and Dr Rango Dietrich Implementing pharmaceutical regulatory guidelines is a complex matter. Reading these regulatory procedures, understanding them and putting them into practice not only requires time but often also assistance – and here it is: the current regulatory guidelines as an audiobook with qualified comments based on long years of industrial and consulting experience. The requirements stipulated by GMP (Good Manufacturing Practice) for the preparation of investigational medicinal products are regulated in Annex 13. Many interfaces to GCP (Good Clinical Practice), the QP (Qualified Person) and to the entire supply chain have to be translated professionally into real processes. Dr Rango Dietrich provides comments on the most important texts, drawing on over twenty years of experience, to make the texts easier for the listener to understand.