New USP Proposals on "Supply Chain Integrity"

An interesting article of the USP on the future USP chapters for supply chain integrity and security can be found in the Pharmacopoeial Forum 40(2).

Supply Chain Integrity and Security (SCIS) is defined as a set of procedures and technologies which are used to ensure visibility and traceability of products within the supply chain.

This aims to protect end consumers against counterfeit products. The ultimate aim is to detect falsified products and prevent them from entering the supply chain and thus the market.

The risks may include:

  • Adulteration of the material or product
  • Misbranded products containing unlabeled ingredients 
  • Expired products that are relabeled and sold to end-users
  • Materials or products meant for destruction
  • Materials and products that are not effectively recalled 

Among the risks involved in the supply chain security is mainly theft of products during storage and/ or transportation which frequently occurs in the practice.

At the end of this guideline, you can find an appendix listing the definition of various terms like:

  • Adulteration - storage of a material "under insanitary conditions", non GMP-compliant conditions which may have an influence on the quality of the product.
  • Counterfeit Drugs
  • Diversion - "The unlawful redirection of pharmaceutical products [...] to legal and illegal markets"
  • Economically motivated adulteration - Production of fraudulent products with the intention to make an economic gain.

More information about the new Chapter <1083.4> can be found on the USP website of the Pharmacopeial Forum (PF).

Source: USP

Go back


Stay informed with the GMP Newsletters from ECA

GMP Newsletter

The ECA offers various free of charge GMP newsletters for which you can subscribe to according to your needs.

To subscribe, please click here.