News

In July 2018 the US FDA issued a Warning Letter to an Indian sterile manufacturer. The content of the letter primarily affects the inadequate procedure with OOS results. Besides, further deviations like in the visual inspection and the facility maintenance have been criticized.

More

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.

More

Almost 2.500 GMP inspections were performed last year by EU/EEA inspectors. And still many of them in the US.

More

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.

More

Quite a few supervising authorities in the health care sector come for GMP inspections also to foreign countries. Read what the Brazilian ANVISA and the Mexican COFEPRIS will expect.

More

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

More

The US FDA announced two updated programmes: the Quality Metrics Feedback Program and the Quality Metrics Site Visit Program.

More

The Maltese competent authority has performed an initial inspection at the facility of an Indian manufacturer and packer in March 2018. This resulted in a Non-Compliance Statement regarding GMP.

More

Batch certification by a QP is one of the essential requirements in the EU GMPs. However one company in Spain has released products to the market without the QP - with reasonable consequences.

More

The European Medicines Agency (EMA) has published an updated set of questions and answers on the impact of the MRA between the EU and the US addressing questions with GMP relevance.

More
x
Search