Quality

Jun 18, 2015
By BioPharm International Editors
The agency takes action against websites that illegally sell unapproved medications.
Jun 17, 2015
By BioPharm International Editors
The agency streamlines risk and mitigation information.
Jun 14, 2015
BioPharm International eBooks
Quality-risk management tools can assist biopharma companies in mitigating risks when outsourcing crucial elements of the drug-development process.
Jun 04, 2015
Drug quality issues have forced the National Institutes of Health to shutter its in-house facility for producing clinical supplies for certain clinical trials.
Jun 04, 2015
Agency officials visit China to meet with Chinese regulators and industry representatives about keeping the pharma supply chain safe.
Jun 03, 2015
By BioPharm International Editors
FDA cites 17 observations including air handling, quality control, and deficient microbial monitoring at NIH’s Clinical Center Pharmaceutical Development Section.
Jun 03, 2015
By BioPharm International Editors
The agency cited VUAB Pharma, located in the Czech Republic, for cGMP deviations.
May 31, 2015
BioPharm International
This article reviews factors that affect protein stability at different steps of the product manufacturing process and strategies to minimize their impact on product quality.
May 31, 2015
BioPharm International
This article reviews the definition of HCPs, risks posed by HCPs, regulatory concerns, commonly accepted ELISA methods for HCP measurement and their limitations, and orthogonal methods available for HCP characterization.
May 19, 2015
By BioPharm International Editors
The former New England Compounding Center will pay $200 million to victims and creditors for the 2012 outbreak of meningitis that killed 64.