Dublin, Dec. 04, 2024 (GLOBE NEWSWIRE) -- The "Analytical Methods Validation for FDA Compliance Drugs and Biologics" training has been added to ResearchAndMarkets.com's offering. Dependable analytical ...
USP’s Diane McCarthy on the emerging standards platform and opportunities for stakeholders to help shape standards evolution.
A former US Food and Drug Administration (FDA) official said the agency’s draft guidance on setting up inspection testing programs for detecting visible particles in injectable drugs is meant to ...
The process of method modernization, which involves integrating advancements in system and column technology for routine analysis, is a challenge many regulated laboratories face due to a larger focus ...
In-house harmonization of excipient specifications ensures compliance with multiple pharmacopoeias, reducing redundant testing and aligning with global regulatory expectations. Specification ...
Compendial methods rely on Nuclear Magnetic Resonance (NMR) to meet this need. This whitepaper demonstrates how the USP-NF and Ph. Eur. NMR assay procedures for HP-β-CD and SB-β-CD can be effectively ...
Dublin, Feb. 27, 2025 (GLOBE NEWSWIRE) -- The "3hr Virtual Seminar - Validation, Verification and Transfer of Analytical Methods - Implementing Guidelines from FDA/EMA, USP and ICH" training has been ...
Automated quality control using rapid PCR assays is replacing 28-day culture tests, cutting biopharmaceutical lot release ...
Learn about the when, why and how USP works with industry stakeholders and other pharmacopeias to develop the monographs within the USP-NF. Leaders in the industry take a very proactive approach in ...
DUBLIN--(BUSINESS WIRE)--The "Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)" conference has been added to Research ...
DUBLIN--(BUSINESS WIRE)--The "Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)" conference has been added to ...
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