All United States Pharmacopeia (USP) articles
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NewsPharmacopeial Discussion Group releases major particulate contamination update
Revisions to the harmonised general chapter “Particulate Contamination (Q-09)” aim to improve pharmaceutical drug development.
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NewsVulnerable medicine list to aid US medicine supply resilience
The analysis from the US Pharmacopeia (USP) provides a mitigation strategy for manufacturers and other stakeholders to improve reliability of medicines amidst supply chain challenges.
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ArticleAdvancements and knowledge gaps in ICH Q2(R2)
In this article, experts from USP’s Analytical Procedure Lifecycle Joint Subcommittee explore the latest advancements in ICH Q2(R2) guidelines on validation of analytical procedures and their implications for industry. They highlight areas that would benefit from additional guidance and compare how the latest ICH Q14/Q2(R2) guidelines align with US pharmacopeial approaches.
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NewsWidening adoption of animal-free reagents for endotoxin testing
If the proposed USP Chapter on using non-animal derived reagents is approved, it will be published for early adoption in November 2024, USP states.
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NewsUSP recommends revisions to proposed RMM chapters
Revisions for two proposed USP chapters recommend changes for rapid tests required for releasing sterile short-life products, as well as for rapid microbiological methods (RMM) for detecting contamination in these products.
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NewsUSP General Chapter <660>—Glass revised
To create opportunity for glass innovation, the Packaging and Distribution Expert Committee (PD EC) revised the United States Pharmacopeia (USP) General Chapter —Glass.
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NewsProposed non-animal derived reagent Chapter published
USP’s proposed new Chapter , which offers additional information on Bacterial Endotoxins Tests (BETs) using non-animal derived reagents, has been published as a General Announcement in advance of public consultation.