Today, it is common for pharmaceutical products to be sourced in a complex maze of processing and handling throughout the course of manufacturing, storage, and distribution--all against a global supply-chain backdrop. Before a product even reaches the patient, it is likely that multiple ingredient manufacturers, suppliers, and distributors from different parts of the world have had a hand in making, storing, and handling the finished drug product. Multiply this complex chain of events by the number of available drugs and countries involved in both producing and consuming medicines and the vulnerable areas within the global pharmaceutical supply chain become quite evident. In response to the rapid transformations taking place in the global pharmaceutical supply chain, the United States Pharmacopeial Convention (USP) is developing and revising standards to aid manufacturers, transportation providers, and other stakeholders to deal with many of these complex issues.
USP’s proposed suite of general chapters
To help protect product quality, USP is developing a series of informational general chapters on good distribution practices that will appear in the United States Pharmacopeia--National Formulary (USP-NF), USP’s compendia of public quality standards. Detailed in a stimuli article published in the July-August 2013 issue of Pharmacopeial Forum (PF)--USP’s free, online journal for posting and receiving public comments to developing standards--the chapters are being developed in a collaborative effort involving four USP Expert Committees: Compounding; Monographs--Excipients; Packaging, Storage, and Distribution; and Physical Analysis.
The general chapters will address four key areas, highlighting key principles as well as practices related to good distribution:
• Quality management system. Topics will include documentation control and resources management; nonconformances, complaints, and corrective actions; and the role of continuous improvements.
• Good importation and exportation practices. Topics will include audits and supply agreements; container seals, cargo inspection, customers, and brokers; and verifying product and firm compliance with regulations.
• Supply-chain integrity and security. Topics will include adulteration and counterfeiting; diversion and theft; and product recall procedures.
• Environmental control management. Topics will include building/facility (storage), transportation vehicles (shipping), and controlled-temperature environments.
For its proposed general chapter on environmental control management, USP’s Expert Committees are placing a strong emphasis on understanding the environmental impacts to which a product may be exposed during distribution. By framing the chapter in terms of management of environmental controls, USP encourages manufacturers to look at external factors that could affect product quality whether in cold-temperature, ambient, or extreme heat conditions.
This chapter also addresses cold-chain products, for which many well-established robust temperature monitoring systems are available. Measures such as packaging systems with dry ice and containers with active cooling systems are often employed to help ensure product quality throughout the course of distribution and many regulations currently exist that specifically address shipment of cold-chain products.
Aligned with its current thinking about the role that environmental control management plays in product quality, USP is also proposing a change in its definition of “controlled-room temperature.” USP’s current temperature range for a usual and customary working environment is 20 to 25 °C. In a stimuli article in the November-December 2013 issue of PF, USP proposes the expansion of this range to 8 to 30 °C. In part, the motivation for this change is to encourage companies to put broader temperature ranges on product labels, allowing for greater flexibility in how products are distributed. The appropriateness of expanding the temperature range for a product is based on stability data that have been generated on the product.
Public comments on USP proposed standards
Comments to the November-December stimuli article on USP’s definition of “controlled-room temperature” will be received until Jan. 31, 2014. USP’s proposed suite of general chapters on good distribution practices is scheduled to publish in PF in early 2014. For more information or comments on these standards, please direct all communications to Desmond Hunt at [email protected]
Desmond Hunt, PhD, is senior scientific liaison, General Chapters, US Pharmacopeial Convention, [email protected]