Drugmakers using a sterility assurance release program can take a pass on sterility testing of finished units, according to FDA guidance. In a parametric release program, a drugmaker's demonstrated ...
Dublin, Aug. 22, 2025 (GLOBE NEWSWIRE) -- The "U.S. Pharmaceutical Sterility Testing Market Size, Share & Trends Analysis Report By Type (Outsourcing, In-house), By Product, By Test (Sterility Testing ...
Nelson Labs, a Sotera Health company and a specialist in microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries, now performs ...
BOCA RATON, Fla.--(BUSINESS WIRE)--LGM Pharma, a leading provider of tailored API and CDMO services for the full drug product lifecycle, announced today the expansion of its Analytical Testing ...
Sterility concerns and out-of-spec testing results are two common sources of drug recalls. Now, the problems have hit two drugmakers at once. For one of the companies, it's far from the first time the ...
A domestic research team has developed a technology that can complete sterility testing of pharmaceuticals in just one day. Previously it took two weeks (14 days) to check the results, but this ...
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