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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 11, 2021
EMA has clarified its position on the European approval process of the Sputnik V vaccine.
February 10, 2021
Pharma companies find ways to maintain quality standards, despite pandemic-related restrictions.
The selection of a new FDA commissioner has become a contentious issue in Washington, as the White House delays a decision and interest groups line up behind competing candidates.
FDA sent a warning letter to Allay Pharmaceuticals for inadequate written procedures; inadequate out-of-specification testing; inadequate stability testing; and inadequate quality control oversight.
The importance of characterizing excipients, supply chain security, and the role of novel excipients are explored.
Representatives of industry organizations discuss crucial business, regulatory, science-based issues facing the industry.
The agency is developing guidance to help manufacturers make changes to existing COVID-19 vaccines to treat new variants in the coronavirus.
February 04, 2021
The company recently installed a fully validated visual inspection system that uses artificial intelligence in an automated inspection machine.
PathoQuest will apply its experience in viral safety testing and quality control of biologics for mitigating the risk of adventitious agent contamination in biopharmaceutical manufacturing.
February 03, 2021
This article provides an overview of the key risks that can be associated with the use of secondary reference standards (RS) and illustrates scientific challenges associated with transitioning from pharmacopeial RS to secondary RS.