United States Pharmacopoeia (USP) revised General chapters on Good Distribution Practices (GDP)

USP has revised General Chapters on Good Distribution Practices (GDP). The revision is highlighted in a new USP chapter the safety and integrity of the supply chains for starting materials and medicinal products. 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.

A new series of General Chapters on the different aspects of the pharmaceutical supply chain ("Good Distribution Practices") should substitute 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. So that’s the reason these GDP chapters should be reorganized from a higher perspective.

The chapter covers 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 four main GDP topics are now organized as follows:

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

The ultimate aim is to identify falsified or manipulated products and prevent them from entering the supply chain - and, as a matter of fact - the market.