Quality Systems

Mar 15, 2018
BioPharm International
Drug manufacturers can improve use of quality agreements in contract manufacturing.
Mar 15, 2018
BioPharm International
The author reviews operative options for the implementation of a quality oversight and how companies can benefit from this function from a regulatory perspective.
Mar 13, 2018
By BioPharm International Editors
Revisions to chapters on glass containers and elastomeric closures were canceled following review of comments.
Mar 09, 2018
By BioPharm International Editors
The European Medicines Agency has called for the immediate suspension and recall of AbbVie and Biogen's multiple sclerosis drug Zinbryta (daclizumab beta).
Mar 08, 2018
The FDA commissioner outlined the agency's initiatives to reward innovation and biosimilars development.
Mar 07, 2018
By BioPharm International Editors
The agency has approved a new HIV treatment for patients with "limited treatment options".
Mar 06, 2018
By BioPharm International Editors
The company is recalling Methylprednisolone Sodium Succinate for Injection, USP, 40mg, 125mg, and 1g manufactured by Gland Pharma Ltd and distributed by Sagent due to out-of-specification impurity results.
Mar 06, 2018
By BioPharm International Editors
The company is recalling three lots of Hydromorphone HCl Injection USP CII 10 mg/mL, 1 mL in 2 mL Single Dose Vials because of possibly empty or cracked vials.
Mar 01, 2018
BioPharm International
Biologic new molecular entities (NMEs) accounted for 26% of total NME approvals in 2017.
Mar 01, 2018
BioPharm International
Spectroscopic tools present an alternative method for reliable at-line process monitoring and control.
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