GMP Reports

Book Series on GMP Implementation

The "GMP REPORT" is a publication series intended to facilitate the implementation of current GMP guidelines in pharmaceutical operations. There are no fixed publishing intervals or periods.

The first issue covers "FDA Requirements for cGMP Compliance". Twelve authors from the pharmaceutical industry illustrate the efficient implementation of FDA's cGMP requirements in routine operations.

The second issue "The Qualified Person", provides an overview of the applicable European legislation framework and relevant guidelines. The legal duties of the QP like batch certification are introduced and discussed. The aspect of the QP's discretion in certifying a batch in the case of deviations and OOS results, the possibility of delegating tasks, the responsibilities within the quality system and also necessary skills a QP needs for the daily business are reflected in various articles.

Experts from international pharmaceutical companies as well as from the national authorities share their experience on these issues and give first-hand information of what is expected from QPs nowadays and in the future.

The GMP Publication section of the ECA Academy Website provides further information as well as an online books shop. The reports are issued by the Editio Cantor Verlag (ECV) in Aulendorf, Germany. The editor of these book series is Concept Heidelberg.