From Concept to Medicine - A Comprehensive Drug Development Journey

19 - Materials Management: From Raw Materials to Finished Products (S15E5)


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Explore the comprehensive world of materials management within a GMP framework, understanding how it ensures the quality and consistency of pharmaceuticals and dietary supplements. Discover the importance of rigorous supplier qualification, going beyond price to assess reliability, quality commitment, and adherence to specific requirements. Learn how inventory control manages the flow of materials through a facility, preventing mix-ups and ensuring proper storage conditions to avoid contamination and deterioration. Delve into the critical role of sampling procedures, ensuring representative samples are collected for accurate quality assessment.

This episode also highlights the importance of scientifically valid test methods and calibrated equipment in analyzing samples and verifying compliance with predefined acceptance criteria. Understand the process of material rejection and the procedures for handling returned products, emphasizing the focus on patient safety. Explore the significance of documentation throughout the materials management process, creating a traceable record of every step. Finally, consider the future challenges of materials management in an increasingly globalized supply chain and the ongoing need for vigilance and innovation.

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From Concept to Medicine - A Comprehensive Drug Development JourneyBy Jim Mitchell

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