News

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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On June 25, 2013 the US FDA published a new Good Manufacturing Practice Guide for Cosmetic Products. Please read more here.

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The level of cooperation between inspectors and assessors when handling "QbD" applications involving RTRT (Real Time Release Testing) was added to the Q&A part of the EMA's website in June 2013. More information can be found in the News.

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Medicines regulator implements innovative software to analyse risk data and target inspection activity. Read more.

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