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GMP News No. 364
13 November 2003
CurrentInspection Findings of the
According to the Freedom of Information Act (FOI), inspection findings ofthe FDA are open to the public. In contrast to this, one seldom hears aboutinspection findings of European supervisory authorities. John Taylor of theBritish supervisory authority MHRA presented inspection findings of hisauthority on the occasion of the Education Course of the European ComplianceAcademy (ECA) titled "GMP Compliance Auditor," which was held inBarcelona from 28 to 29 October 2003.
MHRA is the result of the fusion of the Medicines Control Agency and theMedical Devices Agency, which took place in April this year.
The MHRA has laid down an inspection interval of 2 years for their ownmanufacturers (700) and an interval of 3 years for "third-countrymanufacturers" (300).
The MHRA classifies its inspection findings as "critical,"major," and "others."
"Critical" characterises a deficiency that indicates asignificant risk that a product could or would be harmful to a patient, or adeficiency that has produced a harmful product. A combination of"major" deficiencies that indicates a critical systems failurealso belongs in this category.
A "major" deviation is a non-critical deficiency that could orwould produce a product that is not in compliance with its marketingauthorisation. Or it stands for a combination of "other"deficiencies that is a sign of a major systems failure, or for a number ofrepetitive "other" deficiencies.
A deficiency in the category "other" is a deficiency thatcannot be classified as either "critical" or "major,"but still indicates a GMP deviation.
Contamination risks rank 1st and 2nd on the top tenlist of all inspected areas (including third countries, wholesalers, andcontract laboratories; cp. illustration 1). As a consequence, contaminationrisks 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 pharmaceuticalindustry (cp. illustration 3).
The following tables show GMP deviations in third countries and theirtrends (cp. illustration 4 and 5).
What is also very interesting is the list of serious "GoodDistribution Practice" deficiencies (cp. illustration 6). It isstriking that temperature control and monitoring in the store itselftogether 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 toAnnex 18. The five most frequent deficiencies were: