Pharmacopoeia harmonization provides better support for global regulatory agencies and addresses the global nature of bio/pharmaceutical manufacturing and supply. In this context, it may be suggested ...
The US Pharmacopeia (USP), the Japanese Pharmacopoeia, and the European Pharmacopoeia "Microbial Limits Tests" are in the final stages of harmonization. The harmonized USP chapters are slated for ...
Researchers recently developed a harmonized, validated way to use imaged capillary isoelectric focusing (icIEF) to evaluate the charge heterogeneity of monoclonal antibodies (mAbs). The new method is ...
The latest revisions to international pharmacopoeia standards for glass pharmaceutical packaging has seen further harmonization for testing requirements and see a continual increase in the necessity ...
Pharmaceutical industry officials have proposed the United States Pharmacopeia (USP) develop a new harmonized chapter on visual inspections of parenteral drugs that would address current testing gaps.
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