GMP News - Inspections/Audits

The US Food and Drug Administration (FDA) announced that it accepted four new states, which will now benefit from the EU-US Mutual Recognition Agreement MRA.

An inspection by EU inspectorates in collaboration with EDQM has revealed significant GMP violations at a Valsartan manufacturer's site.

The US FDA has published a so called internal Manual of Policies and Procedures (MAPP) describing how the agency will prioritise its pharmaceutical inspections.

On the basis of a GMP inspection performed at an Italian sterile manufacturer, the Italian authority (AIFA) recommended the recall of batches and issued a GMP non-compliance report. Read more about the GMP deficiencies observed.

During an inspection in March 2018, the French competent authority discovered various GMP violations at the site of an Indian manufacturer. Learn more about the Non-Compliance Report issued on behalf of the EMA.

The aim of the International API Inspection Programme is the cooperation of authorities in monitoring and controlling API manufacturers. Read here, by which measures an optimised bundling and efficiency enhancement of the regulatory supervision of API facilities via GMP inspections are to be reached.

EU inspectorates already accept inspections of the FDA at US sites. But there will still be auditors coming from the EU to the US.