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EU Pharmaceutical Industry Starting to Incorporate More QbD-Like Elements in Applications; EU Inspectors Looking to Align Inspections with New Paradigm

This article was originally published in The Gold Sheet

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Executive Summary

Quality by Design is advancing in Europe as manufacturers incorporate more QbD elements into their applications and EU regulators begin adjusting their inspections to address QbD-related issues. Decentralized review for most applications slows advance of QbD. Discussion of mock submissions spurs interest. EMEA/EFPIA meeting focuses on QbD issues companies raised privately. PDA launches PCMO initiative for sharing best practices. The increasing pain of over-inspections.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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