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September 15, 2019
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This article provides the legal and regulatory basis for pharmacopoeia compliance and illustrates pharmacopoeia impact throughout the drug product lifecycle.
This article examines the history and evolution of the pharmacopoeias and the particular challenges that must be overcome to achieve harmonization among the pharmacopoeias.
Pharmacopoeia harmonization provides better support for global regulatory agencies and addresses the global nature of bio/pharmaceutical manufacturing and supply.
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.
August 20, 2019
The US Pharmacopeial Convention is proposing a policy change to the inclusion of reporting thresholds in drug substance and drug product monographs.