Quality Systems

Mar 27, 2018
By BioPharm International Editors
Telstar reports that its Boreas, a new 86° ultra-low-temperature freezer, increases average performance by 20%.
Mar 23, 2018
By BioPharm International Editors
The draft guidance addresses the agency’s policy on evaluating bulk drug substances in drug compounding.
Mar 23, 2018
By BioPharm International Editors
The agency’s Committee for Medicinal Products for Human Use recommended six drugs for approval at its March 2018 meeting.
Mar 20, 2018
By BioPharm International Editors
The agency published two new guidance documents detailing postmarketing safety reporting requirements for combination products.
Mar 20, 2018
By BioPharm International Editors
The agency sent a warning letter to Malladi Drugs & Pharmaceuticals Limited after an inspection found CGMP violations that included the presence of vermin.
Mar 20, 2018
By BioPharm International Editors
The agency’s Clinical Data Summary Pilot program will post redacted Clinical Study Reports in order to help stakeholders understand why FDA approved a new drug application.
Mar 19, 2018
By BioPharm International Editors
The European Medicines Agency has published a new tool that gives a transparent overview of the agency’s relocation to Amsterdam.
Mar 16, 2018
By BioPharm International Editors
The agency announced proposed research studies on how healthcare providers and patients understand drug promotional materials.
Mar 15, 2018
BioPharm International
Process validation is an extension of biologics development processes.
Mar 15, 2018
BioPharm International
Contract testing organizations can provide bio/pharma companies with a cost-effective way to adapt to new technologies and regulations.
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