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 […]
Panelists:Gaurav Walia, VP of CSV/CSA/DI & Digital Governance, Head of Chicago PQE Office & Local Equity Partner, PQE GroupCindy Duhigg, Senior Principal, Global Manufacturing Science & Technology Engineering, AlconRebecca Fuller, Vice President, Regulatory Compliance, QualityHub As quality and compliance expectations continue to evolve across the life science industry, organizations are being called to rethink and […]
AI | Article | Data Integrity | GMP | White Paper
Ronald D. Snee, PhDSnee Associates, LLC In the pharmaceutical world we talk a lot about Data Integrity. The FDA (2016) published A guidance for industry on matters involving data integrity. We hear analysts talking about Data Quality. Legal proceedings often question the “Chain of Custody of the Data.” Metadata is also of concern when assessing […]
AI | Article | Data Integrity | GMP | White Paper
Published By VTI Life Sciences Introduction The pharmaceutical industry is undergoing a significant transformation driven by digitization and artificial intelligence (AI). As regulatory expectations from agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) continue to emphasize data integrity, traceability, and compliance, Good Manufacturing Practice (GMP) systems must […]
Created by: Valerie Mulholland, Senior Director / Principle Consultant, GMP Services Ltd & Anne Greene, Director PRST, Technological University, DublinThe Pharmaceutical Regulatory Science Team (PRST), founded in 2005, carries out research into strategies to address the challenges and opportunities of implementing science and risk-based decision making and manufacturing approaches. Since its inception, the PRST has […]
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