Understanding Pharma Guidelines: EU GMP Annex 13

This PharmAudio Guidelines Audio Book deals with the contents of EU GMP Annex 13, which describes the regulatory requirements to be followed for the manufacture, quality control, release and distribution of investigational medicinal products (hereafter referred to as IMP). Internationally, Annex 13 is considered to be the most detailed guideline on this topic and thus represents a global regulatory standard in this field.

Unfortunately, the processes and coherences involved in preparing investigational medicinal products are very complex. This is why operators and professionals not yet very familiar with the fundamentals and details of the GMP environment may have difficulties in practically applying prior GMP knowledge in this field.

The aim of PharmAudio Guidelines audio book is to support the listener in applying the contents of Annex 13. It is therefore mainly intended for people with advanced knowledge about and experience with GMP.