Manufacturing, Fill/Finish

Aug 01, 2015
BioPharm International
Process maps and risk assessments are among the valuable tools operators can apply to reduce the risk of microbial contamination.
Jul 20, 2015
By BioPharm International Editors
Baxter has initiated a voluntary recall of two lots of IV solutions due to the potential presence of particulate matter.
Jul 10, 2015
By BioPharm International Editors
The new project will increase fill/finish manufacturing capacity for select products on FDA’s Drug Shortage Index.
Jul 01, 2015
BioPharm International Multimedia
By BioPharm International Editors
Bill Hartzel, Director Strategic Execution, Advanced Delivery Technologies at Catalent Pharma Solutions, spoke with BioPharm International about blow-fill-seal for aseptic processes.
Jul 01, 2015
BioPharm International
Humans represent the greatest risk for microbial contamination in an aseptic process.
Jun 24, 2015
By BioPharm International Editors
The agency clarifies its requirements for allowable excess volume and labeled vial fill size in injectables and biologics.
Jun 19, 2015
By BioPharm International Editors
NIH provides an interim corrective action plan to correct deficiencies found in its Clinical Center Pharmaceutical Development Section.
Jun 15, 2015
BioPharm International
Automation and disposables continue to reduce human error.
Jun 05, 2015
Drug quality issues have forced the National Institutes of Health to shutter its in-house facility for producing clinical supplies for certain clinical trials.
Jun 04, 2015
By BioPharm International Editors
FDA cites 17 observations including air handling, quality control, and deficient microbial monitoring at NIH’s Clinical Center Pharmaceutical Development Section.
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