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GMP News

MAT Survey by the British NC3Rs

The British National Centre for the Replacement, Refinement & Reduction of Animals in Research (NC3Rs), with the support of other European authorities, the FDA and industry representatives, has published a survey on MAT in pyrogen testing and is calling for participation.

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EMA Questions & Answers on Mutual Recognition Agreement (MRA) with US updated

Update EU/US MRA: EU can now also rely on FDA third-country inspections. This can be found in the updated Q&A document.

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FDA continues to take Root Cause Analysis and CAPA very seriously

The FDA is currently citing significant deficiencies in root cause analysis, CAPA implementation and monitoring by the quality assurance unit (QU) with increasing frequency. This is also the case in a recent Warning Letter to a company in the USA.

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