Pharmaceutical Technology, December 2024

Legal and Regulatory Perspectives on 3D Printing: Drug Compounding Applications

December 10, 2024

Peer-Reviewed Research

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This paper explores the legal and regulatory framework around 3D drug printing, particularly for personalized medicine, considering regulatory compliance, business concerns, and intellectual property rights.

Complying with CGMPs for Sterile Manufacturing

December 02, 2024

Ask the Expert

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All CGMP requirements, including supporting activities, are critical in aseptic sterile manufacturing to ensure product quality and patient safety, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.