OOS results include those that fall outside the specifications or acceptance criteria established in New Drug Applications (NDAs), official compendia, or by the manufacturer.
Glossary
Out of Specification (OOS)
02.27.12
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Breaking News | Drug Development | Industry News
Veklury Reduced Risk of Hospitalization in High-Risk COVID-19 Patients
Veklury demonstrated a statistically significant 87% reduction in risk for the composite primary endpoint of COVID-19 related hospitalization.
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Breaking News | Industry News
ANI Acquires Branded Products Portfolio from Sandoz
Enter multi-year manufacturing and supply agreement.Charles Sternberg, Assistant Editor
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Scale-up/Technology Transfer
Ensuring Quality During the Transfer and Scale Up of Rx Drugs
Defining the key parameters and considerations for a successful technology transfer.Tom Chang, President, Bora Pharmaceutical Laboratory Co. Ltd.
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Aseptic Processing | cGMP Manufacture | Facilities | Fill/Finish
Innovative Manufacturing Technology for Aseptic Filling
V-CRT: Combining quality and OEE advantagesGerald Buerkle, Vice President Production, Vetter Pharma-Fertigung GmbH & Co. KG
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Breaking News | cGMP Manufacture | Clinical Trial Materials | Industry News | Solid Dosage/Creams/Ointments
IriSys Doubles Contract with NCI for Mfg. Clinical Trial Materials
The contract is for development and production of new therapeutic agents for use in clinical trials supported by NCI
