Inside USP: A Holistic Approach to Supply-Chain Integrity

Listen to USP officials speak about supply chain integrity as part of a video series. Go to PharmTech.com/PharmTechTV and click on the "USP" tab.

One of the most daunting challenges facing pharmaceutical companies is securing the long and complex supply chains that are typical in today's global industry. From the sourcing of raw materials to final delivery to the pharmacy, practitioner or patient, the number of nodes in the global supply chain for a medicine is astounding, with each link presenting an opportunity for the insertion of risk or harm. Although most companies have highly sophisticated, multifaceted approaches to addressing this challenge, approaches vary.

In addition, there can be huge differences in approach not only between large and small or medium pharmaceutical manufacturers, but also among raw-materials suppliers, logistics providers, and the plethora of other companies involved in the production, distribution, and delivery of medicines to patients.

For example, many companies involved in the chain do not handle pharmaceuticals as their primary business. Despite the good work and due diligence that a pharmaceutical company, wholesale distributor, or other supply-chain stakeholder may employ, the effort can be rendered useless at the seemingly smallest breach. Wherever the breach occurs, someone may be there to take advantage. In the pharmaceutical supply chain, therefore, every step is important, and a company truly is only as strong as the weakest link.

To address this issue, the US Pharmacopeia (USP) recently published a proposed set of recommended best practices on supply-chain integrity, for which it is seeking broad input. If followed, these best practices will help ensure that medicines can be traced back to their original manufacturer, are not adulterated or counterfeited, and are transported to their intended destination with quality intact.

The proposal is contained in the draft USP–NF General Chapter <1083> "Good Distribution Practices—Supply Chain Integrity," which is published in the March–April Pharmacopeial Forum (PF) [38(2)].

Once in its final form, the general chapter will document what is envisioned to be a universal approach for helping to achieve supply-chain integrity. The general chapter is informational (i.e., nonmandatory), but USP hopes that the chapter can be a resource for companies that need to be brought up to speed on supply-chain issues and that it can serve as mechanism for building consensus across different industries.

Scope of the USP supply-chain chapter

The USP Packaging, Storage and Distribution Expert Committee, which is responsible for the new general chapter, has been interested in this topic for several years and sees the new proposal as one of an eventual suite of distribution chapters, following on the widely used General Chapter <1079> "Good Storage and Shipping Practices." Supply-chain integrity—which involves minimizing risks that arise anywhere along the supply chain—may be too broad for just one general chapter, however. That is one of the key questions USP has for industry and other stakeholders as it asks for feedback on the new chapter's contents.

USP expects the general chapter to evolve significantly from its draft, and hopes the public vetting will result in a strong final product that will be valuable to all relevant parties, including manufacturers; transportation companies involved in automobile, truck, rail, sea and air services; third-party logistics providers, freight forwarders and consolidators; brokers, importers and exporters; packaging and repackaging operations; wholesalers and distributors; retail, mail-order, hospital, nursing home and other pharmacies; and mail distributors, including the US Postal Service and other expedited shipping services.

The general chapter <1083> provides recommendations on how to minimize risk in international supply chains through effective partnerships and manufacturing quality systems. As it is written, the chapter covers four main areas:

• Importation, which details three primary initiatives importers should undertake to help prevent and detect potential risks (i.e., supply-chain risk management, development of effective supplier partnerships, and building a supply-chain quality system).

• Counterfeit Drugs and Medical Devices, which documents types of counterfeit drugs, medical consequences, and distribution and extent of counterfeit drugs and devices.

• Best Practices to Combat Counterfeit Drugs and Medical Devices, which covers packaging technologies (e.g., tamper-evident designs, authentication technologies and serialization); drug pedigrees; machine-readable data carriers (e.g., two-dimensional [2D] barcodes and radiofrequency identification [RFID] tags); repackaging guidance; information retention and security; best anticounterfeiting practices, and more.

• Diversion and Theft, which addresses factors that raise the risk of theft of drug products and components; security systems, devices, and procedures that should be implemented to reduce risk; and critical information to be gathered after a theft.

The practices included in the general chapter are top-level, and are purposefully nonprescriptive so as not to box companies in to one way of doing something. The general chapter intends to set a framework; companies can use the best approaches for them within that framework. When discussing track-and-trace technology, for instance, USP points to the two most widely recognized options: RFID and 2D barcodes. It is not, however, USP's role to decide on the actual technology to be implemented.

USP's role in supply-chain integrity

There has been much discussion in the industry regarding the challenges posed by a global supply chain, and yet, there are no overarching, comprehensive industry-wide practices to date. What does exist is piecemeal, with pockets of information available through FDA guidance, trade organizations, and other sources. USP believes it can provide value as a convener of different stakeholders. The organization can bring disparate views together and help organize the prevailing thoughts, finding commonalities among all players. In addition, through its inclusion in USP–NF—compendia widely recognized both domestically and internationally—recommendations put forth in a general chapter can have more weight than, for example, a technical report.

Finally, with USP–NF in a continuous state of revision, a mechanism exists for consistently updating the recommendations to reflect current realities. Because change is constant, USP's Expert Committee will be charged with monitoring whether there is a need for adapting the general chapter, thereby providing all parties with one central place for up-to-date information.

Industry participation

Given the complexity of this topic, USP is seeking extensive input from all the parties that have an interest in the new general chapter <1083>. Although the expert committee responsible for the chapter represents a diverse group of manufacturers, pharmacists, and other experts, USP is seeking additional perspectives to assist in providing a strong final product. The draft general chapter being published this spring may be deemed too broad or too specific, or may evolve into multiple chapters, for instance.

USP will evaluate all of these considerations based on feedback received from the diverse stakeholder community. In addition to comments obtained via the PF, USP is planning a Supply Chain Integrity Workshop at its headquarters in Rockville, MD, on May 22-23, 2012, to further solicit input. The workshop will seek to clarify USP's role in supply-chain integrity and address key topics such as related regulation and technology, and the roles and responsibilities of all parties in the supply chain. The workshop will have a strong international component as well.

Anthony DeStefano, PhD, is vice-president of general chapters, and Desmond Hunt, PhD, is a senior scientific liaison, both at the US Pharmacopeial Convention (USP).