About the GMP-Auditor Association

The quality system element of Auditing constitutes a fundamental pillar in all contract giver and contract acceptor constellations under GMP and GDP. Auditing is used to ensure the quality system remains current and operating, in other words it is a tool for continues improvement.

Despite its central role no GMP regulation explicitly defines the term audit, its contents, or guidance in the procedures for planning, scoping, preparation, execution, documenting and or consequences of observations, as well as the follow-up or management of periods for mitigation of any deficiencies. Additionally, there is limited availability of standards addressing risk based planning of audits.

Although never replacing audits performed by manufacturers Health Authority inspections basically follow equivalent principles, some of which are public as compilation of procedures for inspectors of EU inspectorates.

As we have experienced, our supply chains have become more and more global with additional (specialized) parties, generating complexity as well as the  need for increasing number of audits to be performed as part of due diligence. The higher awareness of GMP for APIs, GDP for APIs, GDP for Medicinal Products, Appropriate GMPs for Excipients and wider use of IT and other services, increase the number of required audits significantly. Pharma companies using contractors more often, therefore the need for oversight of these contractors, whether they are suppliers of materials or manufacturers of the finished products.  The industry needs to select, develop and train more auditor to be able to deal with its approach to management of supply chain.

Under pandemic conditions on-site audits were drastically reduced, with distant assessments by Health Authorities and remote audits by MIAHs became an often used alternative. The enforced use of distant audits provided a fundamental change to the risk profile of supply chains and the supervision of such supply chains by the means of auditing.

The professional community basically agrees that distant audits have significant weaknesses and limitations. At the same time, too many on-site audits just for the sake of fulfilling the approved audit plan, did not (in the pre-pandemic times) deliver an optimized cost benefit ratio either. The GMP auditor Working Group was founded by the ECA Foundation to support the optimisation of audits performed by the industry applying a balanced wide-ranging approaches  for the future, including after pandemic restrictions.

In November 2023, the European GMP-Auditor Working Group was reorganised to become the European GMP-Auditor Association. It is the goal of the Association to represent Auditors for GMPs, Audit and Inspection Preparation Managers and other individuals involved in a secure pharma supply chain.

Board of Directors

The following colleagues form the Board of the European GMP-Auditor Association:

David Abraham Chair U.K.	Ian Holloway former GMP/GDP/GCP Inspector at MHRA U.K.	Dr Afshin Hosseiny ECA France	Dr Felix Kern Merck Germany	Ágnes Kis form. GMP-Inspector at OGYÉI (Hungary) Switzerland	Thomas Højsholm Schmidt CSL Behring Switzerland	Wolfgang Schmitt Concept Heidelberg Germany	Dr Ingrid Walther Pharma Consulting Walther Germany

 

Authority Advisory Board

The Authority Advisory Board is not part of the legal structure. The Advisory Board Members support the GMP-Auditor Association on a case by case decision and not for all of its activities. The following Board Members of the ECA Foundation Board support the GMP-Auditor Association:

Dr Christian Hösch
GMP-Inspector, Ministry of Justice and Consumer Protection, Hamburg
Germany