EU: More Inspections and GMP Non-Compliance Statements

Recommendation

13/14 December 2023
Berlin, Germany

Root Cause Analysis
A CAPA Workshop on Successful Failure Investigation

The EU GMP inspectorates inspected more drug manufacturing facilities in 2017, according to the 2017 Annual Report from the European Medicines Agency (EMA). Also more inspections are now performed in the EU. Last year 2.122 inspections were conducted by EEA authorities in the EU/EEA (1.956 in 2016) and seven GMP Non-Compliance Statements were issued (five in 2016). Altogether, 2.493 inspections were performed worldwide (2.293 in 2016) leading to 17 GMP Non-Compliance Statements.

On the other hand, according the report, "the number of GMP inspections requests within the context of centralised marketing procedure declined in 2017". This decrease also reflects the implementation of the EU-US MRA. With this agreement, the equivalence of supervisory standards are recognised, inspection reports of the FDA can be accepted and inspections on each other's territories are reduced.

Source: European Medicines Agency Annual Report 2017.