Quality Systems

Jul 01, 2017
BioPharm International
Continuous processing of 100 g of monoclonal antibody in 24 hours has been demonstrated using lab-scale equipment.
Jul 01, 2017
BioPharm International
CDER’s Janet Woodcock endorses modern drug manufacturing to ensure access to safe and reliable medicines.
Jul 01, 2017
BioPharm International
Single-use bags containing toxic or hazardous materials required special handling.
Jul 01, 2017
BioPharm International
While the measurement of the toxicity of leachables is not always a required parameter, the information collected during these studies could inform future bioprocessing runs.
Jul 01, 2017
BioPharm International
This article presents a general strategy for authorship of deviation investigations, with primary focus on regulatory inspection success.
Jul 01, 2017
BioPharm International
The opening presentation gives the company a chance to put their best foot forward, according to Siegfried Schmitt, principal at PAREXEL.
Jul 01, 2017
BioPharm International
This column presents a data case study of a laboratory refrigerator and its qualification performance over five days, with important lessons for using average and individual results, as well as user requirements.
Jun 19, 2017
By BioPharm International Editors
The company has voluntarily recalled Clindamycin Injection USP ADD-Vantage Vials to the hospital/retail level because of a lack of sterility assurance.
Jun 16, 2017
By BioPharm International Editors
The company is voluntarily recalling all unexpired lots of nitroglycerin products produced at its Houston location for potency issues.
Jun 16, 2017
By BioPharm International Editors
The company recalled a variety of products due to the potential of microbial contamination.
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