OR WAIT null SECS
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.
September 02, 2020
The 2020–2025 EMRN strategy will be regularly reviewed over the coming five years to accommodate science and technology advances.
The companies have entered into a strategic partnership for the CMC development and manufacturing of Ansun’s biologics pipeline.
An assessment can identify the critical systems and the gaps in compliance based on intended use, says Siegfried Schmitt, vice president technical, Parexel.
The guidance recommends steps to detect and prevent nitrosamine impurities in pharmaceutical products.
The agency is reviewing an application for Dexamethasone Taw for treating adult patients with COVID-19.
The agency sent a warning letter to Acella Pharmaceuticals detailing CGMP violations and failures to oversee contract manufacturers.
The agency sent a warning letter after an inspection of the company’s Sangareddy District, India found inadequate cleaning procedures.
August 31, 2020
Hahn promises transparency in the review and approval of COVID-19 vaccines.
Under expanded FDA authorization, Gilead Sciences’ antiviral treatment for COVID-19 can be administered to all hospitalized patients.
August 24, 2020
FDA issued an emergency use authorization for COVID-19 convalescent plasma treatments following a report on NIH concerns about insufficient studies and data.