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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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EudraGMDP is the central database for GMP and GDP compliance. Inspections which have been performed by any of the EU member state inspectorates are published in the database. Please get the details about the GMP non-compliance findings at 11 manufacturers in Europe and abroad.

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Supplier Qualification is more than auditing. Supplier qualification can be seen as a risk assessment tool. But what are the exact requirements for qualifying suppliers?

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We are often asked about the acceptance of third GMP audits at API manufacturers. The background for this is that more and more organisations offer such audits. Now, the question is what do you have to pay attention to?

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The Italian Medicines Agency published a "Non-Compliance Report" on radiopharmaceutical manufacturing and a suspension of the manufacturing authorisation.

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In March 2015 the Slovenian GMP Inspectors have conducted a GMP Inspection at the company Polydrug Laboratories PYT. LTD. in Maharashtra, India. Now it seems that both Health Canada and the US FDA have used the GMP inspection report of the Slovenian Authority to decide on consequences for supplies to Canada and the US. Read more about the compliance actions taken against Polydrug.

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