Two Non-Compliance reports to API manufacturers from the Far East published in the EudraGMDP database reveal once more that basic requirements laid down in the ICH Q7 Guideline are not implemented. Read more details about those Non-Compliance Reports.
The Non-Compliance reports in the Eudra-GMDP database of the European Medicines Agency (EMA) are – to a certain extent – the European counterpart of FDA’s Warning Letters. These reports are first drawn up then put in the database after a GMP inspection performed by a representative of the European national competent authorities at an API or medicinal product manufacturer showed serious GMP deficiencies. Similar to Warning Letters, the consequences of Non-Compliance reports are for the companies concerned critical, e.g. withdrawal of the GMP certificate or product recalls.
Two Non-Compliance reports issued at the end of last year concerned API production sites in China and India.
Regarding the Chinese manufacturer “Minsheng…
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