Quality Systems

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.
Aug 01, 2017
BioPharm International
Managing and prioritizing risk is essential to ensuring raw material quality. USP is developing new guidelines to make the work easier.
Jul 31, 2017
By BioPharm International Editors
Stainless-steel particulates were found in one lot of 0.9% Sodium Chloride Injection, USP 1000 mL, prompting the recall to the hospital/user level.
Jul 26, 2017
Weak or faulty quality systems can hurt a company at every stage of a product’s lifecycle.
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