GMP News No. 648
8 December 2005
Analysis of GMP Inspections by MHRA
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.
John Taylor also presented a trending for the British pharmaceutical industry (see 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.
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).
With regard to deficiencies in the manufacture of investigational medicinal products, too, the QM system is among the top 3 (see illustration 6).
On a voluntary basis, the MHRA also conducts inspections of API manufacturers according to Annex 18. The five most frequent deficiencies were:
|If you are interested in the detailed requirements of ICH Q7A (Annex 18), we recommend you the ICH Q7A Training Courses in Barcelona from 30 January to 3 February 2006.|
|The European Compliance Academy organises seminars on all frequent GMP deviations. Click here to view a list of events.|
on behalf of ECA