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Supplier qualification standard aims to strengthen supply chains for quality medicines, dietary supplements, and foods

Quality Matters

Supplier qualification standard aims to strengthen supply chains for quality medicines, dietary supplements, and foods USP’s supplier qualification standard became official on Aug. Global supply chains are complex and vulnerable to disruption.

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Thinking differently about excipient quality to ensure medicines supply chain resilience

Quality Matters

By consensus, the panel emphasized the importance of implementing crucial measures, such as appropriate excipient testing, supplier qualification, and risk management through harmonized standards and regulations. Sourced from suppliers around the world, excipients are relied on by developers of finished medications everywhere.

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How to Help Avoid Tragedies Linked to Contaminated Cough Syrup

Quality Matters

Diethylene glycol can find its way into the supply chain in several ways, through mislabeled products, human error, or through intentional adulteration by manufacturers or suppliers to achieve higher profits. The 1937 incident in the U.S. Pharmacopeia (USP). josh.levin@usp.org Mon, 12/05/2022 - 10:14 Medicines

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Ensuring Product Safety: U.S. FDA Guidance on Testing High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol

Quality Matters

However, with so much focus on the quality of active ingredients in the complex pharmaceutical supply chain, the quality of inactive ingredients is, at times, overlooked. The guidance requires complying with the identity standards for a drug, including drug components, with a name recognized in USP-NF. In May 2023, the U.S.