GMP News - Inspections/Audits

25.06.14

FDA issues Warning Letter for API Facility

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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04.06.14

India under Pressure: GMP Conformity Not Guaranteed in many APIs Facilities

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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14.05.14

Next FDA Import Alert for Indian Manufacturer due to GMP problems -also EU Inspectors find major GMP deviations

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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23.04.14

Another FDA Import Alert for an Indian Manufacturer due to GMP problems

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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23.04.14

FDA wants to increase Number of foreign Inspections

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

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16.04.14

GMP Non Compliance Reports - Update in EMA Database

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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26.03.14

FDA publishes 2014 Annual Inspections Report

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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19.03.14

FDA issues Import Alert for two Chinese Companies

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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05.03.14

FDA: More Inspections in India

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

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05.03.14

Indian Regulators promote two levels of GMP

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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11.02.14

What is FDA Readiness exactly?

Many pharmaceutical companies would like to achieve a so-called "FDA Readiness". But what should be understood under this term? Read more here.

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29.01.14

85 Company listed with GMP-Non Compliance Statements in the New EMA Database

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.

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29.01.14

FDA: more Inspections in 2014

With their new budget, FDA will be able to increase drug plant inspections worldwide and especially in China. Read more.

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18.12.13

FDA plans significant increase of GMP Inspections in China

For quite some time, the US FDA has elaborated concrete plans to increase the number of inspections in China. These plans were developed as a consequence of the Heparin crisis. Based on a new agreement with China, the US FDA will now increase the number of inspections significantly. Read more.

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24.10.13

How to share Audits

Because of ongoing globalisation and outsourcing activities, more and more audits have to be performed. A possibility in saving resources is sharing an audit. Read more about a service offered by the European QP Association.

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