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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.
February 02, 2020
Complex protein structures pose analytical challenges that can be addressed by advanced mass spectrometry technologies and workflows, which can be used to comprehensively characterize them.
February 01, 2020
How to adopt win-win strategies and understand quality agreements for complying with cGMP when building strategic relationships with pharmaceutical contract research organizations.
January 31, 2020
The company’s new Milliflex Oasis System provides enhanced result reliability, increased productivity, and advanced traceability.
January 28, 2020
The agency has published seven guidance documents directed at the development and manufacture of gene therapies.
January 27, 2020
The agency celebrates the efforts it has made in creating a system for the evaluation and supervision of medicines throughout the European Union.
January 22, 2020
FDA revised the guidance after industry feedback and to clarify CGMP requirements for outsourcing facility operations.
January 21, 2020
The agency’s joint Big Data Task Force and the Heads of Medicines Agencies proposed actions for the use of big data to support innovation and public health.
January 17, 2020
FDA sent a warning letter to Health Pharma USA after an inspection found the company’s quality unit was not properly overseeing its drug manufacturing operations.
January 16, 2020
FDA has granted fast track designation for Novavax’s NanoFlu, a recombinant quadrivalent flu vaccine, for use by adults age 65 years and older.
January 15, 2020
Tracking and implementing label changes are crucial to the lifecycle of a marketed drug product.