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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.
June 24, 2016
The agency has suspended recommendation of Riluzole Alkem due to flawed study results.
The agency publishes draft reference material for implementation of FDA’s quality metrics guidance.
June 23, 2016
China’s State Council issued a notice authorizing a trial plan for a new drug marketing authorization holder system for 10 provinces.
June 22, 2016
OPKO’s newly approved extended-release capsule uses Catalent’s OptiShell softgel capsule technology.
The Pharmacopoeial Discussion Group approved monographs and plans to harmonize several others.
The agency cited the company for sterile manufacturing violations.
The two agencies have set up a working group on involving patients in drug development.
June 20, 2016
The assay, co-developed by Grifols and Hologic, will be used to test blood donations in the United States.
Emergent is seeking approval for the manufacture of BioThrax at the company’s large-scale manufacturing facility.
June 17, 2016