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It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.
Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.
Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. ecosystem.
October 07, 2021
The agency received a marketing authorization application a monoclonal antibody treatment for COVID-19 patients.
October 04, 2021
Vaccine access campaigners have projected a request to waive vaccine patents onto the hotel where the annual conservative party conference is being held.
October 03, 2021
Part 1 of this article series demonstrates, using real-world process data, that the four fundamental assumptions underlying the classical Shewhart control charts—randomness, independence, constant average, and constant variation—are often not met.
October 02, 2021
Almost half of pharmaceutical industry profits continue to come from biopharmaceuticals.
Updates to Ph. Eur. include validated tests for N-nitrosamine impurities in sartan APIs.
Public health challenges have highlighted the need for agility in maintaining the quality of medicines.
A new program will test the safety and suitability of new inactive ingredients to encourage the accelerated adoption of FDA-accepted excipients in drug development.
Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about aseptic processing.
October 01, 2021
Appili Therapeutics and AiPharma Global Holdings announced a strategic alliance to advance the global development of a broad-spectrum antiviral treatment in oral tablet form for the treatment of COVID-19.
FDA and EMA are looking to tap real-world data and real-world evidence more broadly to accelerate the research and market approval process.