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An inadequate access control to the data processing of analytical chromatographic system means in all cases that data can be manipulated. A Warning Letter recently published gives an impressive example of insufficient data integrity in the area of quality control.

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From September 26 to September 29 the US FDA published four Warning Letters. One company is located in China and the other three are based in Europe. Read more about the four FDA Warning Letters

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The U.K. MHRA has published a blog and gives some insight in an audit performed as part of the Joint Audit Programme (JAP) for EEA GMP Inspectorates.

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It has been a hot inspection summer. FDA Warning Letters and EU Non-Compliance Reports seem to increase at the moment. It is worrying that the GMP non-compliance issues apparently get more serious than in the past. But what is the reason for the increasing GMP non-compliances?

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EudraGMDP is the European Database for GMP and GDP Compliance information. The database receives a lot of attention from industry because of the GMP and GDP Non-Compliance Reports. Now, the database has been changed without notice and has caused some confusion. Read more about the updated EudraGMDP Database.

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Asia has been in the centre of attention when it comes to GMP non-compliance. This time the company KO DA Pharmaceuticals Co has been inspected by FDA and received a Warning Letter. Read more about the FDA Warning Letter here.

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EU Non-Compliance Reports for two sites of a US based company have been published leading to a withdrawal of the GMP Certificate and a stop of supplies into the EU.

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Would the implementation of TTIP bring an end to FDA inspections in the EU? This is discussed in the EU proposal for a respective annex on medicinal products.

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The number of GMP inspections increased by 35% in 2015, according to the 2015 Annual Report of the European Medicines Agency EMA, which was recently published.

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Various competent authorities are performing inspections. But who is subject to such an inspection?

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