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INTERNATIONAL PHARMACEUTICAL QUALITY
Inside the Global Regulatory Dialogue
IPQ Monthly Update – June / July 2017 in Review
The issue opens with a review of the key priorities of the European Pharmacopeia and its ongoing initiatives to address them. Included are the pharmacopeia’s efforts in ICH Q3D implementation and in the biotherapeutics and co-processed excipient arenas. The second story focuses on MS-based multi-attribute methodology (MAM) and the increasing attention it is drawing in the industry/regulator dialogue. The attention reflects the potential MAM has already shown in biomolecule characterization, design and development, and the challenges involved in realizing its full potential in streamlining QC release and supporting advanced/continuous processing.
