Integrity and Security of Medicinal Products Supply Chains - New Instructions in the US-American Pharmacopeia (USP)

A new series of General Chapters on the different aspects of the pharmaceutical supply chain ("Good Distribution Practices") which should replace the current chapters on the topic has been published in the Pharmacopoeial Forum 40(1). A review of the current chapters (<1079>, <1083> and <1197>) has shown that the contents partly overlap each other. That's why these GDP chapters should be reorganised from a higher perspective.

The chapters address material flow beginning with initial procurement and continuing throughout the supply chain to delivery to the end user. They apply to APIs, excipients, as well as to medicinal products and medical devices.

The 4 main GDP topics are now organised as follows: 

  • 1083.1 Quality Management System
  • 1083.2 Environmental Conditions Management
  • 1083.3 Good Importation and Exportation Practices
  • 1083.4 Suppy Chain Integrity and Security

Supply Chain Integrity and Security (SCIS) is defined as a series of policies, procedures, and technologies which are used to ensure visibility and traceability of products. The ultimate objective is to identify falsified or manipulated products and prevent them from entering the supply chain - and, as a matter of fact - the market.

You can find all information on the USP website of the Pharmacopeial Forum (PF).
Source: USP -

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