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USP Guidelines to Facilitate Supply Chain Integrity

2012/1/10 16:32:02

Contents
contractpharma.com

The U.S. Pharmacopeial Convention (USP) has proposed a set of recommended best practices to help ensure supply chain integrity with comprehensive public standards across the pharmaceutical industry.

The proposed guidelines cover five main areas: Good Importation Practices, Counterfeit Drugs and Medical Devices, Best Practices to Combat Counterfeit Drug and Medical Devices, Diversion and Theft, and Natural Disasters.

The new proposed standard, which is not mandatory, is contained in the USP General Chapter <1083> Good Distribution Practices—Supply Chain Integrity. The proposal is intended to serve as a central guidance outlining the essential elements of an effective strategy.

The proposed standard covers four main areas: Importation (detailing three primary initiatives to help prevent and detect potential risks), Counterfeit Drugs and Medical Devices (documenting types of counterfeit drugs, medical consequences, and distribution and extent of counterfeit drugs and devices), Best Practices to Combat Counterfeit Drug and Medical Devices, and Diversion and Theft (addressing factors that raise the risk of theft of drug products, drug components and medical devices).

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