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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.
December 03, 2021
High price tags threaten to block patient access to potentially life-saving cures and treatments.
The authors introduce the idea of asymmetrical tolerance intervals as an aid in fully assessing product performance relative to product or process requirements.
While supply chain disruptions have resulted in many alterations to workplace practices, they have also presented an opportunity to get ahead of changes to the EU’s upcoming revision of Annex 1.
December 02, 2021
The new General Chapter “Nitrosamines Impurities” by USP became official on Dec. 2, 2021, in the United States Pharmacopeia—National Formulary.
EMA has fully validated the marketing authorization application for Atara Biotherapeutics’ off-the-shelf allogeneic T-cell therapy, tab-cel (tabelecleucel), with an approval decision expected in 2022.
Particle analysis is a critical component of pharmaceutical development, providing assurances of the quality and performance of the final dosage form.
The need for medicines to combat COVID-19 has impacted the way regulatory agencies carry out their operations.
We have broken rules, invented new ones, and engineered stronger institutions and supply chains that will serve us better going forward.
December 01, 2021
Different methods to calculate limits for impurities will give different answers. The prediction interval method may be ideal.
November 29, 2021
The Comirnaty vaccine received a positive opinion from the EMA’s CHMP for children five to under 12 years of age.