EMA Report Shows Higher GMP Non-Compliance in India

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 05-18-2017 15:16


A report by the European Medicines Agency (EMA) shows that in 2016, European inspectors issued non-GMP compliance statements to 11% of Indian sites visited compared to 1% globally.

The information is from EudraGMDP, a database operated by the EMA that supports the exchange of information on GMP compliance as well as on manufacturing and importation authorizations conducted by regulatory authorities in the European Economic Area (EEA) (composed of he European Union member states and Iceland, Liechtenstein, and Norway). 

In terms of actual inspections by EEA authorities inside the EEA  and from facilities outside of the EEA manufacturing products for the European market, approximately 1% of the GMP inspections conducted globally led to the issue of a non-compliance statement (24 out of 2,293). India had the highest number of non-GMP compliance statements issued, 12, and had 96 GMP certificates issued overall, with the non-GMP compliance statements representing approximately 11% of inspection activity.

The 12 non-GMP compliance statements from facilities in India was more than double the number of non-GMP compliance statements from facilities elsewhere. Facilities in the EU/EEA had five non-GMP compliance statements issued, and 1,951 GMP certificates issued, so non-GMP compliance statements represented 0,25% of the facilities inspected. Facilities in China had four non-GMP compliance statements issued, and 55 GMP certificates issued, so the non-GMP compliance statements represented 6.8% of the facilities inspected. Facilities in the US were issued three non-GMP compliance statements, and 86 facilities received GMP certificates, so non-GMP compliance statements were issued to 3.4% of the facilities inspected by EEA authorities. 

Source: European Medicines Agency 


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