News

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

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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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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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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.

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A new FDA document is supposed to provide a consistent approach to the handling of submissions of investigational new drug applications (INDs) within the Center for Drug Evaluation and Research (CDER). This concerns the processes within the FDA as well as the communication with the applicant. More information is available in this News.

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FDA is proposing a regulation to implement administrative detention authority during inspections, which might present a new risk to facilities. Read more.

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