According to the Freedom of Information Act (FOI), inspection findings of
the FDA are open to the public. In contrast to this, one seldom hears about
inspection findings of European supervisory authorities. John Taylor of the
British supervisory authority MHRA presented inspection findings of his
authority on the occasion of the Education Course of the European Compliance
Academy (ECA) titled "GMP Compliance Auditor," which was held in
Barcelona from 28 to 29 October 2003.
MHRA is the result of the fusion of the Medicines Control Agency and the
Medical Devices Agency, which took place in April this year.
The MHRA has laid down an inspection interval of 2 years for their own
manufacturers (700) and an interval of 3 years for "third-country
manufacturers" (300).
The MHRA classifies its inspection findings as "critical,"
major," and "others."
"Critical" characterises a deficiency that indicates a
significant risk that a product could or would be harmful to a patient, or a
deficiency that has produced a harmful product. A combination of
"major" deficiencies that indicates a critical systems failure
also belongs in this category.
A "major" deviation is a non-critical deficiency that could or
would produce a product that is not in compliance with its marketing
authorisation. Or it stands for a combination of "other"
deficiencies that is a sign of a major systems failure, or for a number of
repetitive "other" deficiencies.
A deficiency in the category "other" is a deficiency that
cannot be classified as either "critical" or "major,"
but still indicates a GMP deviation.
Contamination risks rank 1st and 2nd on the top ten
list of all inspected areas (including third countries, wholesalers, and
contract laboratories; cp. illustration 1). As a consequence, contamination
risks are also among the top five of critical deficiencies found by the MHRA
(cp. illustration 2).
Illustration 1
Illustration 2
In addition, John Taylor presented the trends for the UK pharmaceutical
industry (cp. illustration 3).
Illustration 3
The following tables show GMP deviations in third countries and their
trends (cp. illustration 4 and 5).
Illustration 4
Illustration 5
What is also very interesting is the list of serious "Good
Distribution Practice" deficiencies (cp. illustration 6). It is
striking that temperature control and monitoring in the store itself
together with the lack of SOPs or inadequate SOPs account for more than 50%
of the deficiencies.
Illustration 6
On a voluntary basis, MHRA also conducts API inspections according to
Annex 18. The five most frequent deficiencies were:
