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A structured, risk-based framework for pharmaceutical compounding that enhances quality, regulatory compliance, and process consistency.
3d render, number six glowing in the dark, pink blue neon light | Image Credit: © NeoLeo - stock.adobe.com
Pharmaceutical compounding, particularly in 503A and 503B environments, involves complex formulation and regulatory challenges far beyond academic theory. This summary of our extensive article on this topic—written by industry professionals Paul Pluta RPh, PhD, Alan Mancini RPh, Nishant Thakar, RPh, PharmD, and Varanya Chaiyaperm, RPh, PharmD—distills the essential technical and operational takeaways from a comprehensive, six-stage model of pharmaceutical compounding. Ideal for professionals in drug development, manufacturing, QA/QC, and regulatory compliance, this summary emphasizes real-world application, risk mitigation, and alignment with quality frameworks like Quality by Design, Good Manufacturing Practices (GMP), and Quality Risk Management (QRM).
The six-stage compounding model offers a structured, risk-aware approach to compounded drug development. For pharmaceutical manufacturing professionals, it ensures regulatory alignment, enhances process reproducibility, and reinforces a culture of quality and accountability across the compounding lifecycle.
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