GMP-Auditor Forum Release of ECA´s new GMP-Auditor Guide

In this new format, GMP-Auditors can discuss current topics and exchange opinions and experiences with other auditors in moderated session. The presentations will address specific topics deemed important for GMP-Auditors.

A team of experts have developed a new ECA Good Practice Guide “ECA Code of Practice for GMP Auditors”. The guide considers feedback from GMP inspectors, the pharmaceutical industry and suppliers as well as practical experiences from real project cases. Experts working on this guide will be present so participants will have the opportunity to discuss current challenges around GMP Auditing.

All delegates will receive a free copy and the possibility to download the current guide free of charge.

Manufacturers are obliged to carry out GMP audits at their suppliers’ and contract manufacturers’ premises or have them carried out by suitably qualified and trained external auditors. Authorities emphasise the need for on-site audits. However, hybrid versions and complete distant assessments also play an important role in the supplier qualification toolbox.

Auditors play a very important role in the pharmaceutical industry and in the life cycle of pharmaceutical products. Their training and experience, and thus also a mutual exchange, is immensely important here.

What makes a good auditor?

An auditor must certainly have extensive specialist knowledge. This means knowledge of the GMP regulations and their implementation. But an auditor must also have the necessary technical and practical expertise to sufficiently understand and question the audited processes.

To do this, an auditor must be unbiased and independent, know appropriate questioning techniques and be able to apply them. It also requires patience, the ability to listen, persistence and determination. Unfamiliar and new situations must not become a problem.

The ECA Certified GMP Auditor certification programme consists of three modules that provide GMP auditors with specialised knowledge and soft skills, including conflict resolution. And auditors gain experience in their daily professional practice. This new GMP Auditor Forum format aims to present and discuss current topics and promote mutual exchange of opinions and experiences.

In the course of establishing the new ECA Working Group and moving towards becoming an Association, it became apparent that ECA wanted to produce a guide for its members.

We decided early on that we would focus on the most important chapters first, rather than waiting until a full guide was produced. This way we could shorten the time to delivery and also have the opportunity to collect feedback and improve content. The first versions of the chapters have different formats and styles as different volunteer teams were involved in their creation. In the future, we will work on further standardisation and add additional chapters. We would appreciate it if you would let us know what else is important to you.
Members of the new GMP-Auditor Association will get free access to an online version, participants of this GMP-Auditor Forum will also receive a hard copy of the first version.

Membership will be free! We will keep you informed.