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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.
November 04, 2020
Experts examine the role technology can play in quality programs at the 2020 Bio/Pharma Virtual Congress.
November 03, 2020
The document provides analytical strategy options for the control of recombinant viral vectored vaccines to support COVID-19 vaccine developers.
Nostrum Laboratories is recalling Metformin HCl Extended Release Tablets because of NDMA above the acceptable daily intake limit.
An optimal engineering design is crucial for aseptic operation and cleaning.
Successful migrations require careful planning to meet business needs and maintain data integrity.
Bio/pharma continues preparations for a no-deal scenario as time for the UK and EU to agree upon a new deal runs out.
November 02, 2020
The agency is balancing a variety of important issues including the review of COVID-19 vaccines.
Industry wants clarification on compliance following the end of the Brexit transition period.
Resolving drug shortages starts with identifying the source of the problem.
Siegfried Schmitt, vice president, Technical at Parexel, offers insight into FDA’s guidance on performing operations during COVID-19.