EMA Reports Increase in GMP Inspections, Lower Noncompliance

August 7, 2018

The European Medicines Agency says inspection authorities from the European Economic Area — which includes the 28 members of the European Union, Norway, Iceland and Lichtenstein — conducted more GMP inspections last year but issued fewer noncompliance statements.

In a report extracted from the EudraGMDP database, the agency logged 2,476 GMP certificates and 17 GMP noncompliance statements for the year, compared to 2,293 certificates and 24 noncompliance statements for 2016.

India drew the most GMP non-compliance statements with seven, while China drew just one. The European authorities issued no non-compliance statements for U.S. operations.

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