Article | Biopharma | GMP | White Paper
Jason Brown*, Adare Pharma Solutions and Kim Huynh-Ba, Pharmalytik, LLC *Corresponding Author Nitrosamine impurities have emerged as a significant challenge in the pharmaceutical industry due to their carcinogenic potential and unexpected presence in various drug products. Regulatory authorities including the FDA, EMA, and WHO have responded with strict requirements for identification, risk assessment, and control […]
Article | Biopharma | GMP | White Paper
Karen R. Zimm, Ph.D.Jeremy Banaszewski, M.S., Temple University Abstract This review article discusses the recent developments surrounding FD&C Red No. 3, a synthetic colorant utilized in various dosage forms. The significance of colorants in product identification and the implications of the FDA’s recent regulatory actions are examined. This article also analyzes historical perspectives, scientific evidence […]
Moderator: Marsha Steed, President, Steed MicroBio Panelists:Elizabeth Brockson, Aseptic Processing and Sterility Assurance Lead in Global Sterility Assurance and Microbiology, TakedaParsa Famili, President and CEO, Novatek International Avoid the most frequent and costly missteps in contamination control during this no-slides-needed webcast. In this practical conversation, we break down the most common microbial contamination failures and […]
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