Quality Control/Quality Assurance

Jul 19, 2018
By BioPharm International Editors
Inspectors found quality issues at bB BioChem Laboratories Inc, a California-based manufacturer of over-the-counter drug products.
Jul 16, 2018
By BioPharm International Editors
Teva Pharmaceuticals, Major Pharmaceuticals, and Solco Healthcare are voluntarily recalling their products containing valsartan because of the presence of N-nitrosodimethylamine.
Jul 12, 2018
By BioPharm International Editors
The agency is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.
Jul 02, 2018
BioPharm International
Knowing and addressing regulatory expectations early on can avoid unexpected delays later, says Siegfried Schmitt, principal consultant at PAREXEL.
Jul 02, 2018
By BioPharm International Editors
Fagron Sterile Services is voluntarily recalling two lots of Neostigmine Methylsulfate 5mL syringes due to mislabeling.
Jul 02, 2018
By BioPharm International Editors
The European Directorate for the Quality of Medicines & Healthcare highlighted the organization’s achievements in 2017, including the first mAb monograph.
Jul 02, 2018
By BioPharm International Editors
The company unveiled its latest innovations to its mass spectrometry portfolio at ASMS in San Diego.
Jul 02, 2018
By BioPharm International Editors
The company’s new LCMS-9030 system is designed for high resolution and accurate mass detection.
Jul 02, 2018
The agency is asking firms to discuss internal quality metrics efforts as part of the approval process for new medical products.
Jul 01, 2018
BioPharm International
BioPharm International asked an FDA spokesperson how the agency plans on handling these issues in the future.
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