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GMP News

Warning Letter to Indian Sterile Manufacturer due to egregious GMP Deficiencies

The nine-day FDA inspection of an Indian pharmaceutical manufacturer had already taken place in October 2023. Due to the numerous and, as the FDA itself writes, egregious GMP violations and the inadequate response to the list of deficiencies by the manufacturer, a Warning Letter has now been issued.

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More FDA Inspections again - also in the EU?

Two reports were recently published showing that the FDA is once again carrying out more inspections. And this is also happening in the EU - despite the MRA.

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EMA: Update of the Q&As on the Topic of "Parallel Distribution"

Once again, the "Frequently asked questions about parallel distribution" have been revised and published on the EMA website. The information provided by the EMA on parallel distribution of centrally authorised medicinal products is set out in six paragraphs in the Q&A catalogue.

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