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Janssen Research and Development
Joseph A. Albanese, director of Analytical Strategy and Compliance at Janssen Research and Development, LLC
September 15, 2019
The authors take a closer look at these ongoing efforts to harmonize compendial standards, with perspective that may be helpful in considering the future direction of pharmacopoeias.
This article provides an end-to-end compendial framework to understand why compliance with pharmacopoeia standards is challenging.
Pharmacopoeia harmonization provides better support for global regulatory agencies and addresses the global nature of bio/pharmaceutical manufacturing and supply.
This article provides the legal and regulatory basis for pharmacopoeia compliance and illustrates pharmacopoeia impact throughout the drug product lifecycle.