Quality

BioPharm International: Apr 13, 2015
By BioPharm International Editors
The European Medicines Agency releases guidelines for addressing and reporting risks associated with medication errors.
BioPharm International: Apr 12, 2015
By BioPharm International Editors
Agency teams work together to encourage manufacturers to seek approval for previously unapproved drugs.
BioPharm International: Apr 09, 2015
By BioPharm International Editors
FDA issues a Warning Letter to Hospira S.p.A. for GMP violations at the company’s Liscate, Italy facility.
BioPharm International: Apr 09, 2015
By BioPharm International Editors
Baxter voluntarily recalls select lots of IV solutions due to possible particulate matter.
BioPharm International: Mar 01, 2015
Enterprise quality management systems can help shift the quality emphasis from corrective to preventive actions.
BioPharm International: Feb 24, 2015
Drug shortages are declining, but they’re still a serious concern for regulatory authorities, policy makers, and bio/pharmaceutical manufacturers.
BioPharm International: Feb 24, 2015
By BioPharm International Editors
The company voluntarily recalls product due to FDA observations of potential sterility problems.
BioPharm International: Feb 23, 2015
By BioPharm International Editors
The agency cites Apotex’s Bangalore facility with quality system failures.
BioPharm International: Feb 17, 2015
By BioPharm International Editors
FDA gives an update on currently approved Risk Evaluation and Mitigation Strategies.
BioPharm International: Feb 17, 2015
By BioPharm International Editors
The agency releases five draft guidance documents related to drug compounding and repackaging.