Quality Systems

May 01, 2018
BioPharm International
A validation plan developed to support a process unrelated to bio-pharmaceutical manufacture is applied to biopharmaceutical processes and systems.
May 01, 2018
BioPharm International
FDA’s commissioner addresses opioid abuse, drug costs, and manufacturing quality.
May 01, 2018
BioPharm International
Monetary benefits will outweigh the hassle of batch record harmonization, says Siegfried Schmitt, principal consultant at PAREXEL.
Apr 30, 2018
By BioPharm International Editors
The company received a complete response letter from FDA in response to the biologics license application for a proposed trastuzumab biosimilar.
Apr 30, 2018
By BioPharm International Editors
The agency updated its list of recommended influenza virus strains that manufacturers should include in vaccines for the autumn 2018 season.
Apr 30, 2018
By BioPharm International Editors
After a review of public comments, USP will not move forward with nomenclature proposal without further FDA collaboration.
Apr 30, 2018
By BioPharm International Editors
FDA sent a warning letter to Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. for failure to follow current good manufacturing practices.
Apr 24, 2018
By BioPharm International Editors
EMA and its new host country have finalized the terms of the agency’s relocation to Amsterdam.
Apr 20, 2018
By BioPharm International Editors
FDA’s Center for Drug Evaluation and Research has published its second annual report on key safety programs and activities.
Apr 20, 2018
By BioPharm International Editors
The agency has released new guidance on the development of new medication-assisted treatments for opioid dependence.
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