Quality Systems

Aug 17, 2018
By BioPharm International Editors
FDA approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector.
Aug 16, 2018
By BioPharm International Editors
FDA sent a warning letter to Apotex Research Private Limited after investigators found current good manufacturing practice violations.
Aug 15, 2018
By BioPharm International Editors
FDA published a resource guide to promote responsible opioid prescribing in the treatment of animals.
Aug 13, 2018
By BioPharm International Editors
BioPharm International spoke with Sharon Ayd, founder & CEO of Ayd Biopharmaceutical Consulting Services, about what the future holds when it comes to ensuring quality in biopharmaceuticals.
Aug 10, 2018
By BioPharm International Editors
The agency issued a warning letter to Canadian API manufacturer, Les Produits Chimiques B.G.R, citing cGMP violations at its API facility in Pointe-Claire, Quebec.
Aug 02, 2018
More consistent and reliable production processes are critical for advancing innovative treatments.
Aug 01, 2018
BioPharm International
The quality of the cell lines used to manufacture biopharmaceuticals are crucial for the production of high-quality, stable biopharmaceuticals.
Aug 01, 2018
BioPharm International
The type of product, the packaging materials being used, and the process and materials used to manufacture the product will determine when E&L data should be submitted to regulators, says Susan J. Schniepp, executive vice-president, Post-approval Pharmaceuticals and distinguished fellow at Regulatory Compliance Associates.
Aug 01, 2018
BioPharm International
More complex biologic samples must be evaluated to ever higher levels of specificity and sensitivity.
Aug 01, 2018
BioPharm International
Frustrated by slow market adoption, Gottlieb maps out new plan for biosimilar competition.
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