Quality Systems

Feb 01, 2017
BioPharm International
Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
Jan 25, 2017
By BioPharm International Editors
The company issues a voluntary nationwide recall due to the presence of particulate matter in a single vial.
Jan 18, 2017
By BioPharm International Editors
EDQM outlines the steps it will take to implement the ICH Q3D guideline on elemental impurities.
Jan 01, 2017
BioPharm International
There is much work to do to achieve efficient, cost-effective production processes.
Jan 01, 2017
BioPharm International
Siegfried Schmitt, PhD, principal consultant, PAREXEL, discusses how to handle audits and inspections during business expansion.
Dec 20, 2016
By BioPharm International Editors
The agency put Baoying County Fukang Medical Appliance Co., Ltd. on import alert after observing violations at the company’s Yangzhou City facility.
Dec 01, 2016
BioPharm International
A consistent approach in assessing risk is an important aspect of successful quality management.
Dec 01, 2016
BioPharm International
Understanding of endotoxin assays and a range of detection technologies are essential for effective testing.
Dec 01, 2016
BioPharm International
Biopharma must see regulators as partners in their efforts to provide safe and effective therapies.
Dec 01, 2016
BioPharm International
John Ward, vice-president of Engineering at Patheon, discusses the potential for cross contamination in the manufacture of biopharmaceuticals.
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