Quality Systems

Oct 01, 2017
BioPharm International
Detecting viral contaminants in biologic-based medicines—and identifying their source—requires a holistic testing approach.
Sep 28, 2017
By BioPharm International Editors
FDA sent a warning letter to Shandong Vianor Biotech Co., Ltd. that claimed the company failed to follow proper data integrity and quality control procedures.
Sep 14, 2017
By BioPharm International Editors
The agency will offer $35 million in funding over the next five years, on research that aims to modernize manufacturing and quality assurance and control (QA and QC) practices.
Sep 14, 2017
Along with particulate control and determination, speakers at the June conference in Rockville, Maryland, examined the role of protein aggregation and immunogenicity
Sep 01, 2017
BioPharm International
The control of biologics microbiological impurities, contaminants, and mimetics is evolving.
Sep 01, 2017
BioPharm International
The differences between the quality control and quality assurance units can be found in their names, according to Siegfried Schmitt, principal consultant at PAREXEL.
Aug 24, 2017
By BioPharm International Editors
The company is voluntarily recalling the products because of potential contamination with Burkholderia cepacia.
Aug 23, 2017
By BioPharm International Editors
FDA sent a warning letter to Bicooya Cosmetics Limited after inspectors found rodent feces at the company’s Zhejiang, China facility.
Aug 17, 2017
By BioPharm International Editors
The company is voluntarily recalling Lorazepam Oral Concentrate, USP 2mg/mL because of misprinted dosing droppers.
Aug 01, 2017
BioPharm International
Investigational failures and discrepancies can be avoided through the proper execution and documentation of investigations.
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