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An industry reflection on the application of the Russian Pharmacopeia to the registration of biologics

An industry reflection on the application of the Russian Pharmacopeia to the registration of biologics

by Emma Howlett | Sep 3, 2021

BioPhorum members have come together to reflect on standards applied to the manufacture of biologics for the Russian Federation market. They have considered the current state described in the Russian Pharmacopoeia and regulations, as well as forthcoming changes in the...
Raw Materials: Supplier change notifications: change areas and requirements

Raw Materials: Supplier change notifications: change areas and requirements

by Emma Howlett | Jun 28, 2021

Change control and periodic re-assessment are an essential part of raw-material lifecycle management to maintain a qualified raw material. In addition, accurate and timely information is also required in risk assessment to identify any raw materials that warrant...

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