News

FDA publishes 2014 Annual Inspections Report

26.03.2014

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.

More

FDA issues Import Alert for two Chinese Companies

19.03.2014

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.

More

FDA: More Inspections in India

05.03.2014

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

More

Indian Regulators promote two levels of GMP

05.03.2014

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

More

What is FDA Readiness exactly?

11.02.2014

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

More

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

29.01.2014

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.

More

FDA: more Inspections in 2014

29.01.2014

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

More

FDA plans significant increase of GMP Inspections in China

18.12.2013

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.

More

How to share Audits

24.10.2013

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.

More

FDA publishes List of GMP facilities producing for the US market (generic drug products and APIs)

24.10.2013

The US FDA has published a comprehensive list of facilities that produce Finished Dosage Forms, APIs under the Generic Drug User Fee Act. Please read more about this list.

More

Search