EMA sees fewer quality defects in ’09 inspections
pharmafile | June 9, 2010 | News story | Manufacturing and Production |Â Â API, EMA, manufacturing, manufacturing complianceÂ
The European Medicines Agency carried out 175 inspections of manufacturing facilities in 2009, a little lower than its target, according to its recently published annual report.
The number of quality defects uncovered by the EMA inspectors came in at 80, slightly fewer than the 85 seen the prior year.
However, “2009 was characterised by several high-profile manufacturing failures, with increasing international involvement demanding considerable resources from the Agency”, notes the report, which is available to download here.
There were 15 product recalls in the year, six fewer than in 2008, it says.
The tally of inspections included two that were conducted jointly with US regulator the FDA as part of a recently initiated collaboration aimed at sharing inspectors’ expertise. The joint inspection project was started in 2008, initially to exchange information on inspection schedules and results, and has now moved onto joint fieldwork.
The project will also explore whether there is potential in the future for mutual recognition of one authority’s inspection by another, easing the burden on overstretched resources and preventing duplication of effort.
This has been something of a controversial issue, however, with some regulators warning that the process could lead to a reduction in the expertise in one agency – at least in some areas – as another takes on a greater share of inspections.
2009 also saw the first of the EMA’s active pharmaceutical ingredient (API) inspections as part of a pilot programme that also involved the FDA, Australia’s Therapeutic Goods Administration and the European Directorate for the Quality of Medicines (EDQM).
The pilot inspection programme got underway at the end of 2008 and is focusing on API manufacturing facilities outside each of the partnering regulatory authorities’ territories. It is scheduled to last for 18 months.
The intention is to identify facilities that are on regulators’ watch lists and might be good candidates for increased scrutiny and joint inspections.
Phil Taylor
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