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October 02, 2016
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the assessment of risk in the processing of intravenous injectable drugs.
This key bioprocessing segment is expecting continued growth
September 23, 2016
Wells Pharmacy Network is voluntarily recalling all of its products due to sterility concerns.
September 14, 2016
FDA sent a warning letter to an Illinois compounding pharmacy for violations of the Federal Food, Drug, and Cosmetic Act.
September 02, 2016
A process-specific preventative maintenance program improves productivity and reliability.
Visual inspection of parenteral vials is the first step in a root cause investigation.
September 01, 2016
Evonik’s parenteral drug delivery and commercial drug product manufacturing in Alabama passes EU GMP inspection.
Improvements to aseptic manufacturing procedures are long overdue. But how feasible is it for manufacturers to modernize fill lines of legacy products?
August 18, 2016
Fresenius Kabi will add to its generic, sterile injectable manufacturing at its Melrose Park, Illinois site.
August 02, 2016
The design of Baxter BioPharma Solutions’ aseptic filling lines provides a case study in customizing containment systems for multi-product lines