Operations and Regulatory Consulting, Quality, Compliance, GMP, Regulatory

EU & US MRA Fully Operational – What You Need to Know!

July 25, 2019 ||
 
Background In 1998, the EU and the US signed a broad Mutual Recognition Agreement (MRA), which included a Pharmaceutical Annex providing for anticipated and limited reliance on each other’s Good Manufacturing Practice (GMP) inspections. However, this Agreement was never fully implemented.
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“The ultimate goal of providing a robust, safe method to transfer solutions in the Manufacturing Facility was achieved and CAI played a major role with this safety initiative.”

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