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.

Securing the Supply Chain with Good Distribution Practices

March 02, 2023

Good distribution practices ensure appropriate physical storage, distribution, and supply chain security, says Siegfried Schmitt, vice president, Technical, at Parexel.

Subsurface Currents

March 02, 2023

That wave beginning to crash over PhRMA’s gunwales may well emanate from a startup mindset, rather than Big Pharma or government policy pundits.

AbbVie Receives Positive CHMP Opinion for Crohn’s Disease Treatment

March 01, 2023

CHMP recommended the approval of AbbVie’s RINVOQ (upadacitinib) as a treatment for adults with moderate-to-severe Crohn’s disease.

Designing Potency Assays for Complex Novel Modalities

March 01, 2023

The further we pursue CGT, the more variability we need to account for in order to engineer consistency into these new products.

Investigational Personalized mRNA Cancer Vaccine Gains Breakthrough Therapy Designation from FDA

February 28, 2023

Moderna and Merck’s investigational personalized mRNA cancer vaccine has been granted Breakthrough Therapy Designation by FDA.

FDA Approves Sanofi Hemophilia Treatment

February 24, 2023

Sanofi’s once-weekly replacement therapy is FDA-approved for prevention and treatment of bleeding episodes in people with hemophilia A.

IRBs Need More Monitoring

February 23, 2023

GAO calls for more oversight of institutional review boards in clinical trials.

FDA Approves First Treatment for Geographic Atrophy

February 22, 2023

Apellis Pharmaceuticals’ Syfovre is a pegcetacoplan injection intended for the treatment of geographic atrophy secondary to age-related macular degeneration.

Drug Solutions Podcast: Progressing Excipients Through Review

February 21, 2023

In this episode, Ana Ladino provides an update on the acceptance of a novel excipient onto CDER’s pilot program.

Forecasting Trends in Pharma Innovation

February 15, 2023

In the coming year, pharmaceutical innovation will be fueled by key trends throughout the quality sector.