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Author: Olivia Calder, Process Engineer at Kneat Solutions Contact Information: olivia.calder@kneat.com An audit trail is a chronological record of events and activities, detailing who, what, when, and where actions occurred. According to the FDA guidance, “Data Integrity and Compliance With Drug CGMP – Questions and Answers,” personnel responsible for record review must also review the […]
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 […]
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 […]
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