At an “OOS Forum 2012” in mid-June in Prague, Czechoslovakia, sponsored by the European Compliance Academy (ECA) in cooperation with Europe’s QP Association, UK Medicines and Healthcare products Regulatory Agency (MHRA) GMP inspector Di Morris presented her agency’s top ten findings from GMP inspections between April 2011 and March 2012 (link provided below).
MHRA’s annual list of deficiencies presented in Prague mirrors those published by the agency each of the last four years, with similar numbers of inspections and findings.
The top six findings (investigation of anomalies, quality management, change control, documentation, CAPA, and complaints/recalls) have remained the same – although not always in the same ranked order. Numbers seven through ten (product quality review, batch release procedures, self inspection, and risk management) have remained the same and in the same order.
EMA, meanwhile, has announced that it has ceased providing a similar summary of its inspection findings.
At a conference on “European GMPs and the Role of the QP” in late June in Bethesda, Maryland, also sponsored by ECA and the QP Association, EMA Compliance and Inspection Scientific Administrator Dimitrios Catsoulacos commented on the EMA “top 40” list and explained that the agency is no longer providing it because it is not a very meaningful sample.
“EMA only conducts inspections of centrally-authorized products,” he pointed out. “This means that most of the products are biotech products. It also means that most of the inspections take place in the US – about 80%. So it is not a representative list of deficiencies of what the inspectors actually see. Inspectorates in the member states that conduct hundreds of inspections every year have a much more representative list than EMA.”
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