Due to the Freedom of Information Act (FOI), the FDA makes their
inspection results available to the public. Very rarely, however, is the
public informed about inspection results of European supervisory authorities.
The MHRA is a very positive exception from this rule. John Taylor from the British supervisory authority MHRA presented
inspection findings of his authority within the framework of the ECA event
"How to Pass EU and FDA Inspections - GMP Compliance Auditor",
held in Prague from 16 to 18 November 2005.
The MHRA was the product of the fusion of the Medicines Control Agency
and the Medical Devices Agency in 2003.
The MHRA set the frequency of inspections of UK manufacturers (700) to
2 years and that of third-country manufacturers (300) to
3 years.
Inspection findings are classified by the MHRA into the categories
"critical", "major" and "others". Here,
"critical" characterises a deficiency that has a significant
influence on the question whether the patient could be harmed by the
product. A combination of "major" deviations indicating a
critical system error are also classified as "critical".
A "major" deficiency could lead to a product that is not in
compliance with the marketing authorisation. Or it stands for a
combination of "other" deviations indicating a system error or
repeated "other" deviations.
In the category "other", you can find the deviations that
cannot be classified as "critical" or "major", but
still indicate a GMP deviation.
In the top-ten list of "critical" and "major"
deviations found in all inspected areas (including third countries,
wholesalers, contract labs), findings regarding the quality system rank
first and third (see illustration 1). Recently, the FDA published
statistics on its inspections carried out between 1/2004 and 3/2005.
Relating to the 6 inspection systems, here the quality system also
ranks first with 47% of all deficiencies.
Illustration 1
John Taylor also presented a trending for the British pharmaceutical
industry (see illustration 2).
Illustration 2
GMP deviations in third countries are often rooted in the ignorance of
European GMP rules. Illustration 3 lists these deficiencies, illustration
4 shows their trends.
Illustration 3
Illustration 4
Another interesting item are the serious Good Distribution Practice
deviations. It is striking that temperature control and monitoring as well
as returns and QS documentation account for more than 50% of the
deficiencies (see illustration 5).
Illustration 5
With regard to deficiencies in the manufacture of investigational
medicinal products, too, the QM system is among the top 3 (see
illustration 6).
Illustration 6
On a voluntary basis, the MHRA also conducts inspections of API
manufacturers according to Annex 18. The five most frequent
deficiencies were:
- Quality system documentation
- Potential for contamination
- IPC
- Starting material sampling and testing
- Training
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