News

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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From time to time we receive "GMP questions" from ECA Members.  Please read the anwer to this question in our GMP News

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We regularly receive questions related to GMP compliance issues. One of the most asked question addresses the topic accreditation of bodies that perform Third Party Audits. Read more in the GMP News.

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