Quality

Apr 27, 2016
By BioPharm International Editors
The company voluntarily recalls product due to particulate matter.
Apr 14, 2016
By BioPharm International Editors
The company has recalled one lot of 50% magnesium sulfate injection, USP due to particulates.
Apr 01, 2016
BioPharm International
The authors investigate discrepancies in the reported efficacy of high-temperature short-time treatment for inactivating mouse minute virus.
Mar 21, 2016
By BioPharm International Editors
Hospira recalls one lot of 8.4% Sodium Bicarbonate Injection, USP, due to particulate matter found within a single-dose glass fliptop vial.
Mar 18, 2016
By BioPharm International Editors
The agency cited Emcure Pharmaceuticals with CGMP violations.
Mar 11, 2016
By BioPharm International Editors
The company recalls one lot of amikacin sulfate injection USP, 1 gram/4mL (250 mg/mL) vials due to the potential presence of glass particulate in one vial.
Mar 07, 2016
By BioPharm International Editors
Sagent Pharmaceuticals issues a nationwide recall of Fluconazole injection, USP, due to out of specification impurity results.
Mar 01, 2016
BioPharm International
Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss how to create a robust CAPA system and how to identify root cause.
Mar 01, 2016
BioPharm International
Real-time GPS technology, better IT connections, and more conservative, controlled shipping temperatures are improving the shipment of sensitive pharmaceuticals.
Mar 01, 2016
BioPharm International
Data integrity is a widespread, global problem that must be addressed.
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