PharmDev Innovations

PharmAudio - Listening to and Understanding of Regulatory Guidelines

An essential aspect of creativity is not being afraid to fail." Edwin Land

Our audiobook provides information about the EU GMP Annex 13 and is now available in the PharmAudio Guidelines product series also with comments in English language.


Annex 13 regulates the requirements stipulated by GMP (Good Manufacturing Practice) for the preparation of investigational medicinal products. Many interfaces to GCP (Good Clinical Practice) the QP (Qualified Person) and to the entire supply chain have to be implemented professionally in the day-to-day operational environment.

Implementing pharmaceutical regulatory guidelines is a complex matter. Reading these regulatory procedures and understanding and implementing them, not only requires time, but often also assistance.

The new PharmAudio series of audiobooks presents the current regulatory guidelines together with qualified comments based on many years of experience in the industry and from consulting.

Dr Rango Dietrich explains the most important texts, centering his comments on over twenty years of experience in the pharma industry (also as a Qualified Person), helping the listener to understand the text quickly.

This new audiobook contains the original text of Annex 13 in English language with comments also in English and is available as Double-CD with Amazon or from PharmAudio directly. The recommended retail price for this version is EUR 17.90 (excl. Postage and incl. 7% VAT, respectively).

The audiobook will also be available for download from the popular download platforms (iTunes,, Amazon, Google Play).

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