The EMA Database EudraGMDP is a major achievement for GMP and GDP compliance information. Since parts of the data are now publicly accessible, it makes it easier to get important information relevant for supplier qualification. In our GMP News we list the 2014 updates for GMP-Non-Compliance.
The so called Food and Drug Administration Safety and Innovation Act (FDASIA) requires the FDA to publish reports on the inspection of registered establishments every year starting with the fiscal year 2013. The first Annual Report is available now. Read more about the Annual Inspections Report.
The US FDA and the European Union have increased their GMP Inspection Systems significantly. As a result more inspections are being performed outside their own territory. Now the FDA has issued an Import Alert for two Chinese manufacturers. Read more about the FDA Import Alert.
GMP deviations and even data falsification have been identified in a number of companies in India. How is it possible that interpretation of FDA and EU authorities on one side and the Indian authority on the other side come to a completely different picture? Read more in our GMP News
As already reported, the EMA has started listing so-called GMP Non Compliance Statements in the EudraGMDP database in addition to Certificates of GMP Compliance. Now, detailed information has been made publicly available. Read more in the News.
