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Aseptic/Sterile Processing

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Defining Risk Assessment of Aseptic Processes

October 02, 2016

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the assessment of risk in the processing of intravenous injectable drugs.

Sterility Concerns Cause Recall

September 23, 2016

Wells Pharmacy Network is voluntarily recalling all of its products due to sterility concerns.

Compounder Cited for Sterile Manufacturing Violations

September 14, 2016

FDA sent a warning letter to an Illinois compounding pharmacy for violations of the Federal Food, Drug, and Cosmetic Act.

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Evonik Birmingham Laboratories Receives Renewal of EU GMP Certification

September 01, 2016

Evonik’s parenteral drug delivery and commercial drug product manufacturing in Alabama passes EU GMP inspection.

Fresenius Kabi Expands US Sterile Injectables Capacity

August 18, 2016

Fresenius Kabi will add to its generic, sterile injectable manufacturing at its Melrose Park, Illinois site.

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