Stimuli to the Revision Process: Overarching USP General Chapters on Good Distribution Practices

The purpose of this article is to present an overview of new USP general chapters on Good Distribution Practices (GDP), which are being developed based on a review of three existing general chapters, Good Storage and Shipping Practices , Good Distribution Practices Supply Chain Integrity , and Good Distribution Practices for Bulk Pharmaceutical Excipients . These three existing general chapters provide information related to the storage, shipment, distribution, and transportation of pharmaceutical components and products. The review showed overlapping and complementary items among these general chapters and highlighted the need to revisit USP chapters on GDP from an overarching perspective. With this intent
established, USP’s Council of Experts involved Expert Committees (PSD EC and PA EC) will propose a series of new general chapters that will replace the existing three. These new general chapters will cover material flow beginning with initial procurement and continuing throughout the supply chain to delivery to the end user for pharmaceutical components and products, medical devices, and dietary supplements. The chapters will address four main GDP topics—Quality Management System; Supply Chain Temperature Management; Good Importation and Exportation Practices; and Supply Chain Integrity—highlighting best practices and principles.

To whom correspondence should be addressed: Desmond G Hunt, PhD, Senior Scientific Liaison, USP, e-mail dgh@usp.org.