GMP News No. 364
13 November 2003
Inspection Findings of the
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).
In addition, John Taylor presented the trends for the UK pharmaceutical industry (cp. illustration 3).
The following tables show GMP deviations in third countries and their trends (cp. illustration 4 and 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.
On a voluntary basis, MHRA also conducts API inspections according to Annex 18. The five most frequent deficiencies were:
The following events deal with the GMP-compliant manufacture according to Annex 18 or ICH Q7A: