Quality Systems

Apr 01, 2017
BioPharm International
The author discusses the impact of prefilled syringe product contact materials and the filling and stoppering process on protein aggregates.
Mar 28, 2017
By BioPharm International Editors
The agency sent a warning letter to Opto-Pharm Pte Ltd. after deficiencies in sterile manufacturing procedures were found at the company’s Singapore facility.
Mar 07, 2017
By BioPharm International Editors
The agency sent a warning letter to Chongqing Pharma Research Institute Co., Ltd. citing data integrity violations.
Mar 01, 2017
BioPharm International
Siegfried Schmitt, PhD, Principal Consultant at PAREXEL, discusses how to mitigate risk in a global regulatory environment.
Feb 28, 2017
By BioPharm International Editors
The agency cited the company’s Kansas facility with CGMP violations similar to problems found at other Hospira facilities.
Feb 27, 2017
By BioPharm International Editors
The company is voluntarily recalling one lot of Edex due to a lack of container closure integrity.
Feb 27, 2017
FDA plans to initiate its quality metrics program as industry continues to push back.
Feb 09, 2017
By BioPharm International Editors
The company is voluntarily recalling product due to particulate matter.
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.
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