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.

Amicus Therapeutics Launches Pompe Disease Therapy in United Kingdom

August 17, 2023

The indication for Pombiliti is a long-term enzyme replacement therapy (ERT) used in combination with miglustat for adults with late-onset Pompe disease (LOPD).

FDA Grants Accelerated Approval to Pfizer’s Multiple Myeloma Treatment

August 16, 2023

FDA granted accelerated approval to Elrexfio (elranatamab-bcmm) for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy.

FDA Releases Guidance on Intake Limits for Nitrosamine Drug Substance-Related Impurities

August 11, 2023

The guidance can help both applicants and manufacturers limit the mutagenic and carcinogenic potential of NDSRIs.

FDA Approves First Oral Treatment for Postpartum Depression

August 11, 2023

The new drug could be a powerful tool for patients suffering depressive symptoms after birth.

Unpacking COVID-19 Pandemic Response

August 10, 2023

Highlights from a wide ranging discussion on COVID-19 pandemic response from Kate Broderick, Chief Innovation Officer at Maravai LifeSciences, and Tom Madden, President & CEO at Acuitas Therapeutics.

FDA Grants Orphan Drug Designation to Treatment of Malignant Glioma

August 08, 2023

The investigational drug was developed to activate a novel uptake pathway, allowing antineoplastic drugs to combat solid tumors more successfully.

FDA Warns that Tydemy May Have Reduced Effectiveness

August 08, 2023

Lower levels of an active ingredient may result in unexpected pregnancies.

Quality Quartets in Risk-Based Qualification: ICH Q9(R1) Considerations

August 03, 2023

Quality Quartets may be used to achieve knowledge-driven, risk-based approaches to commissioning and qualification that are consistent with ICH Q9(R1) principles.

An Intelligent Drug Development Paradigm

August 03, 2023

An intelligent drug development paradigm can enable small pharma to implement an effective early drug development approach.

Progressing Finished Product Inspection Through Automation

August 02, 2023

The industry is taking steps to automate the final product inspection process for complex therapeutics.