Quality Systems

May 13, 2015
By BioPharm International Editors
Supply chain consortium establishes a working group to address quality problems in India.
May 12, 2015
By BioPharm International Editors
The agency publishes draft guidance answering industry questions about the Biologics Price Competition and Innovation Act.
May 07, 2015
The US Court of Appeals granted Amgen’s request to block Novartis’ Neupogen biosimilar, Zarxio, from the US market until the court resolves litigation between the two companies.
May 07, 2015
By BioPharm International Editors
Johnson & Johnson announces partnership with NYU School of Medicine to launch a compassionate care committee for individual patient requests of investigational drugs.
May 06, 2015
By BioPharm International Editors
The company voluntarily recalls select lots of Adrucil due to particulate matter.
May 02, 2015
BioPharm International
Siegfried Schmitt, principal consultant, PAREXEL, discusses how to keep up with changing regulations.
May 02, 2015
BioPharm International
The European Pharmacopoeia defines the format and content of monographs for biologicals to keep pace with recent approaches and meet the needs of its users.
May 01, 2015
BioPharm International
Resonant mass measurement can be used to detect and quantify the formation of protein subvisible particles and to detect and quantify any silicone droplets in a formulation.
May 01, 2015
BioPharm International
The biopharma industry has had some successes but still needs to work on operational issues.
May 01, 2015
BioPharm International
Integrating advances in facility design can meet differing and emerging bioprocessing needs.
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