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

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Integrity and Security of Medicinal Products Supply Chains – New Instructions in the US-American Pharmacopeia (USP)
The revision of the General Chapters on Good Distribution Practices (GDP) has highlighted in a new USP chapter the safety and integrity of the supply chains for starting materials and medicinal products. More information can be found in the News.

GMP News
16/04/2014

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 – http://www.usp.org

 

http://www.gmp-compliance.org/enews_4233_Integrity%20and%20Security%20of%20Medicinal%20Products%20Supply%20Chains%20-%20New%20Instructions%20in%20the%20US-American%20Pharmacopeia%20%28USP%29_8447,S-RPV_n.html

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