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A Non-Compliance Report due to several GMP violations has been issued to a Chinese heparin manufacturer after an inspection conducted by the Italian Health Authority. This report is now available on the EMA website for Non-Compliance Reports.

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In the course of an inspection conducted in October 2018, the Italian health authority discovered several GMP deviations in the areas of sterile manufacturing, packaging and QC testing at an Italian manufacturer. Read more details about the Non-Compliance Report which can now be found in EMA's inspection database.

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In a warehouse in Arkansas, USA, the US Food and Drug Administration (FDA) found "alarming" insanitary conditions.

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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.

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PIC/S adopted a new Guidance on Classification of GMP Deficiencies. It supports the global harmonisation of the classification of GMP deficiencies.

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

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Portugal has been accepted by FDA and will now benefit from the EU-US Mutual Recognition Agreement for inspections.

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

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In a four-page Warning Letter to a contract manufacturer who produces semi-solid OTC products, the FDA criticizes amongst others the missing tests of starting and finished products.

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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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