NEW | EMA update on on-site GMP and GDP inspections

December 12, 2023
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EMA has issued an update regarding the on-site GMP and GDP inspections postponed during the pandemic. Following the end of the COVID-19 public health emergency declareds by WHO in May 2023, on-site GMP and GDP inspections have restarted after being postponed or carrieds out remotelly during the pandemic.

The validity of GMP and GDP certificates was extended until the end of 2023, but the GMP/GDP Inspectors Working Group has decided to continue the extension of validity date until 2024 or the conclusion of the next on-site inspection, whichever comes first, except where clarifying remarks in the document state otherwise.

This announcement comes as a result of the meeting of GMDP IWG held in November and was announced just last week.

You can have a look at the complete document here: GMP EMA COMPLIANCE

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Many key takeaways and highlights from the DIA RAPs Regulatory Policy Forum!! Capitalizing on the success of their joint collaboration this past January for 2024 Combination Products in the EU, DIA and the Regulatory Affairs Professionals Society (RAPS) are coming together once again to produce the 2024 Regulatory Policy Forum.
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