Quality Systems

Steps Towards Demystifying Risk-Based Decision Making

It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.

Computer Validation Confirms Evidence

Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.

Digitalization of QbD Risk Assessments

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.

EMA Publishes Annual Report for 2022

May 17, 2023

The report outlines highlights from the agency’s medicines evaluations and milestones for 2022.

FTC Sues to Block Amgen’s $27.8 Billion Acquisition of Horizon Therapeutics

May 16, 2023

In a brief, the Federal Trade Commission cited concerns about the acquisition resulting in an increased monopoly on Amgen’s newly acquired thyroid eye disease and chronic refractory gout treatments.

Aseptic Processes Safeguard Biologics

May 15, 2023

Aseptic techniques must be practiced throughout all stages of biologics production.

AI Algorithms Find Use in Pharma Equipment

May 15, 2023

Machine learning provides real-time data for process control of high-shear wet granulation.

Pharma-PBM Battles Escalates on Capitol Hill

May 12, 2023

Congress have initiated a range of legislative proposals to further manage PBMs and the pharma market.

EC Authorizes Fabry Disease Treatment

May 11, 2023

EC has granted marketing authorization to Chiesi Global Rare Diseases and Protalix BioTherapeutics for PRX-102 (pegunigalsidase alfa).

Europe Lifts COVID-19 Business Continuity Status

May 10, 2023

EMA and European regulators are lifting their COVID-19 business continuity measures as the pandemic’s peak ends.

FDA Approves First RSV Vaccine

May 10, 2023

GSK’s Alexvy vaccine is the first to receive FDA approval for respiratory syncytial virus.

Quality Quartets in Risk-Based Qualification

May 02, 2023

Quality Quartet Registers connect Quality Quartets to their process system or unit operation “parent.”

High-Quality Communication Enables High-Quality Drug Products

May 02, 2023

User fee programs have improved FDA’s approval timeline for important therapies.