Regulatory/GMP Compliance

Apr 01, 2018
BioPharm International
Updated guidelines and new technologies aid visual inspection of parenteral products and packaging.
Mar 23, 2018
By BioPharm International Editors
The draft guidance addresses the agency’s policy on evaluating bulk drug substances in drug compounding.
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 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.
Mar 15, 2018
BioPharm International
Drug manufacturers can improve use of quality agreements in contract manufacturing.
Mar 13, 2018
By BioPharm International Editors
Revisions to chapters on glass containers and elastomeric closures were canceled following review of comments.
Mar 01, 2018
BioPharm International
FDA enforcement efforts and drug approvals trend upward.
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