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.

New Medicines, Markets, and Manufacture: CRISPR for Sickle Cell Disease and β-thalassemia

November 30, 2023

Exagamglogene autotemcel seen as synechdoche.

Consent Decrees Entered Against Utah Supplement Manufacturer and Distributors

November 20, 2023

Consent decrees were issued against Evig LLC, of St. George, Utah, and Premium Production LLC, of St. George, Utah, for unapproved dietary supplements.

Consent Decree Entered Against Arizona Company

November 20, 2023

The US District Court for the District of Arizona entered into consent decree against Smart Women’s Choice and its CEO to stop the company from distributing unapproved contraceptive drugs.

FDA Approves First Recombinant Treatment for Rare Blood Clotting Disorder

November 14, 2023

Adzynma provides a replacement for low levels of the ADAMTS13 enzyme in patients with congenital thrombotic thrombocytopenic purpura.

EMA Recommends Rare Blood Cancer Treatment and Seven Other Medicines

November 13, 2023

Recommended medicines include treatments for generalized myasthenia gravis, glioma, neovascular age-related macular degeneration, and more.

Europe Publishes Electronic Product Information for Selected Medicines

November 09, 2023

Electronic product information for selected human medicines that have been harmonized across the European Union have been published for the first time.

FDA Publishes Guidance on Container Closure Systems for COVID-19

November 09, 2023

The document includes recommendations for the reporting and implementation of changes to container closure system components.

Discussing E&L Study Design Between ISO and USP (AAPS PharmSci 360)

November 06, 2023

Dujuan Lu, PhD, global leader—E&L, SGS Health Sciences, discusses the differences in how E&L study design should be approached based on whether the study is following ISO or USP standards.

Key E&L Issues to Consider During Formulation (AAPS PharmSci 360)

November 03, 2023

Dujuan Lu, PhD, global leader—E&L, SGS Health Sciences, recommends some key issues that pharma manufacturers should consider when formulating products that require a medical device.

New Biologic Treatment for Hidradenitis Suppurativa Receives FDA Approval

November 03, 2023

This is the second biologic approved to treat HS, a painful and reoccurring skin disease.