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
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.