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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.
May 15, 2023
Aseptic techniques must be practiced throughout all stages of biologics production.
Machine learning provides real-time data for process control of high-shear wet granulation.
May 12, 2023
Congress have initiated a range of legislative proposals to further manage PBMs and the pharma market.
May 11, 2023
EC has granted marketing authorization to Chiesi Global Rare Diseases and Protalix BioTherapeutics for PRX-102 (pegunigalsidase alfa).
May 10, 2023
EMA and European regulators are lifting their COVID-19 business continuity measures as the pandemic’s peak ends.
GSK’s Alexvy vaccine is the first to receive FDA approval for respiratory syncytial virus.
May 02, 2023
Quality Quartet Registers connect Quality Quartets to their process system or unit operation “parent.”
User fee programs have improved FDA’s approval timeline for important therapies.
Guidance for GMP manufacture of emerging therapies has evolved to accommodate innovation and the broader spectrum of products in development, but greater harmonization is still needed.
The concept of quality culture and how to enforce it are being debated by regulators and industry, says Siegfried Schmitt, vice president, Technical at Parexel.