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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.
October 16, 2020
For planned acquisitions or licensing, a careful analysis of CMCl factors is vital to ensure no problem areas are overlooked.
October 15, 2020
Analysts should understand how a monograph, together with the associated general notices and general chapters, relate to their responsibilities under good manufacturing practices.
Ongoing and emerging cyber-risks to legacy operational technology systems in bio/pharmaceutical manufacturing must be addressed.
Building employee participation and forming good habits contribute to a company-wide quality culture that pays off.
Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.
October 14, 2020
Oxular has been granted rare pediatric disease and orphan drug designations by the US FDA for its proprietary drug, OXU-003.
The UK's MHRA has joined the Australia-Canada-Singapore-Switzerland (ACSS) Consortium of regulators.
October 09, 2020
Bio/pharma industry leaders support FDA’s newly published EUA guidance for COVID-19 vaccine authorization.
October 07, 2020
The guidance provides recommendations for data and information needed to support an EUA for COVID-19 vaccines.
October 05, 2020
The agency sent an open letter to European Ombudsman Emily O’Reilly affirming the agency’s intention to apply the same standards to the evaluation of COVID-19 treatments as it does to other medicines.