Quality Systems

What Goes Wrong When API Quality is Compromised?

The nitrosamines contamination in “sartan” drugs emphasized the importance of risk assessment in API ingredients manufacturing.

A Robust Quality Culture Benefits All

Establishing a quality culture ensures a safe and effective product, and saves costs.

Put a Cap on CAPAs

Data may be used to improve (or remove) a corrective action/preventive action.

Drug Product Security

November 28, 2022

High-cost-per-dose large molecules can make a big impact on cell and gene therapy supply chain management.

FDA Approves $3.5 Million Hemophilia B Gene Therapy

November 28, 2022

CSL’s Hemgenix (etranacogene dezaparvovec) will cost approximately $3.5 million, making it the most expensive single-use medicine in the United States.

ACS-Grade Reagents’ Database Launched

November 28, 2022

The complete online database of ACS Reagent Chemicals is now available.

FDA Approves Injection Designed to Delay Onset of Type 1 Diabetes

November 21, 2022

Tzield (teplizumab-mzwv) injection is the first FDA-approved therapy designed to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older.

FDA Committee Recommends Ardelyx Kidney Disease Drug

November 21, 2022

Initially rejected in July 2021, XPHOZAH (tenapanor) won recommendations as both a monotherapy and combination treatment from FDA’s CRDAC meeting.

Element’s New Air Treatment Testing Facility Supports Indoor Space Public Health Air Quality

November 21, 2022

Element has opened a new 7500-ft3 facility that will be used to evaluate aerosolized product efficacy for reducing airborne organisms and viral particles.

Major FDA Reform Unlikely in Closely Divided Congress

November 10, 2022

The results of the mid-term election may reduce Congress’ ability to pass FDA-related legislation during its lame duck session.

UK MHRA Expands Cosentyx License

November 09, 2022

The UK MHRA has expanded the use of Cosentyx for use in pediatric arthritic conditions.

FDA Publishes Draft Guidance Concerning Sameness in ANDAs

November 09, 2022

The latest guidance from FDA discusses recommendations on demonstrating sameness between the active ingredient in a proposed generic drug product and its reference listed drug.

Evolution of Analytical Procedure Validation Concepts: Part I – Analytical Procedure Life Cycle and Compendial Approaches

November 04, 2022

This article provides an overview of validation concept principles evolution to a life cycle risk-based approach with focus on compendial perspectives.