News

The US FDA has issued a Warning Letter to Tianjin Zhongan Pharmaceutical Co. Ltd. in Tianjin, China. The company produces APIs and failed to establish adequate GMP procedures at the facility. Read more about the FDA Warning Letter.

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The pressure on India is getting bigger because of GMP deficiencies found during inspections. An article of the news agency Reuters summarised impressive information on the topic. Read more here about the Reuters article.

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GMP Compliance problems found at more and more manufacturers in India are a major concern of EU and FDA regulators. Again the FDA has issued an Import Alert for an Indian Manufacturer. Please read more.

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The FDA has issued an Import Alert due to serious GMP deviations for an Indian manufacturer. Read more about the FDA Import Alert.

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According to the current Budget Request, FDA would like to perform approx. 20 percent more foreign GMP inspections. Read more.

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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.

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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.

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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.

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During her visit in India, FDA Commissioner Margaret A. Hamburg stated that inspections in India will be increased. Read more.

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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

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