Supplier Qualification in the Focus of EU GMP Inspectorates

 
Supplier qualification is getting more and more in the focus of the authorities and their inspections. This became also obvious during a presentation of John Taylor, Group Manager of the MHRA, at the European Compliance Academy (ECA) Education Course 'Efficient Supplier Qualification' in Prague (03/04 May 2007). John Taylor emphasised that one important objective of supplier qualification is to provide an appropriate level of confidence that suppliers are able to provide materials, components and services of a consistent and acceptable quality and in compliance with regulatory requirements and expectations.

In 2005/2006 more than 4% of all serious GMP deficiencies in U.K. inspections were linked to the interaction with suppliers. That's number 7 in the overall ranking. More observations on this topic were made than for example on cleaning and equipment validation or the design and maintenance of premises.

Even if the authorities don't tend to review audit reports, they expect a sound documentation including an assessment of compliance with the technical requirements and with regulatory requirements where appropriate.
  

Learn more about inspections and audits in the following ECA course:

 
Author:
Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)