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 ...
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 ...
A former US Food and Drug Administration (FDA) official said the agency’s draft guidance on setting up inspection testing programs for detecting visible particles in injectable drugs is meant to ...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 United States Pharmacopeia (USP) is proposing a new approach for its work to support the quality and availability of selected biologic medicines. Building on decades of experience in setting ...
This guide outlines essential knowledge for pharmaceutical quality assurance managers about subvisible particle testing requirements, technology selection, and the development of a compliant, ...
Automated quality control has moved to the center of biopharmaceutical manufacturing strategy, and the clearest evidence is the displacement of weeks-long culture-based tests by rapid polymerase chain ...
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