Quality Systems

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.
Jun 01, 2017
BioPharm International
Increased understanding of potential impurities has spurred efforts to standardize monitoring procedures.
Jun 01, 2017
BioPharm International
Informing your clients of possible changes in equipment is imperative when upgrading a laboratory, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
May 22, 2017
By BioPharm International Editors
The agency has given a green light to a new system for collecting and monitoring suspected adverse reactions.
May 15, 2017
BioPharm International
FDA’s focus on the quality culture and its request for quality metrics may ensure a successful company-CMO relationship.
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