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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.

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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.

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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.

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

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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.

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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.

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

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

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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.

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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.

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