EU Manufacture of Biological Active Substances and Medicinal Products for Human Use

The EC has been busy at work revising the EU guidelines for GMP manufacturing. They just published the GMP revisions to Volume 4, Annex 2. The document becomes effective in January 2013. The document provides guidance on the expanding range of active substances and medicinal products defined as biological. The table below identifies the biologics that are covered within the scope of this document. The document addresses the controls that are needed to ensure the quality, integrity, and control for manufacturing biologics.

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