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Brexit Agreement – what now?

After intensive negotiations, the European Union (EU) and the United Kingdom (UK) agreed on a provisional Trade and Cooperation Agreement on 24 December 2020. By the end of the year, all remaining

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Avoiding Non-Compliance in Packaging Areas

During an inspection of a manufacturer of solid oral dosage forms the FDA observed incidences of water leakage from the ceiling of the encapsulation room: Capsules were exposed to leaks during multiple batch encapsulation operations.

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EMA Distant Assessment Guidance

Currently, on-site GMP/GDP inspections may not be possible because of reasons linked to the Covid-19 pandemic. As a result, Distant Assessments can support and help determining compliance with GMP/GDP principles

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WHO Draft Document on GMP for IMPs

In view of recent experiences from inspections carried out for COVID-19 therapeutics, the World Health Organization (WHO) published a new working document entitled “GOOD MANUFACTURING PRACTICES FOR INVESTIGATIONAL PRODUCTS“. The

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