This article is part of a special issue on Outsourcing Resources
As pharmaceutical supply chains and distribution channels become more complex and global, there are renewed calls from public-health experts and Congress to ensure patient safety by demonstrating that supply chains are secure. A series of recent supply-chain breaches have demonstrated that a compromised supply chain is susceptible to counterfeit, diversion, dilution, tampering, and deliberate contamination—ultimately affecting thousands of patients every day.
In 2009, five bio/pharmaceutical manufacturers, distributors, and suppliers collaborated to form Rx–360, an international supply-chain consortium aimed at enhancing patient safety across the pharmaceutical supply chain. The voluntary group's mission is "to create and monitor a global quality system that meets the expectations of industry and regulators, and that assures patient safety by enhancing product quality and authenticity throughout the supply chain" (1). Today, Rx–360 has 64 members and continues to grow.As part of fulfilling its mission, Rx-360 has begun conducting joint audits of its supplier members with the intention of sharing them with industry. These audits, designed to help establish and share best practices for supply-chain security, are designed to be more thorough than those conducted by individual pharmaceutical manufacturers because they focus on the entire supply chain from the origin of raw materials to shipment of product. Standards for the Rx–360 pilot audit, adopted by the Audit Standard Working Group, are based on the draft Excipact Excipient standard, the International Pharmaceutical Excipients Council/Pharmaceutical Quality Group (IPEC/PQG) Good Manufacturing Practices Audit Guide for Pharmaceutical Excipients, and the Rx–360 Basic Chemicals & Raw Materials Audit Guide (2, 3).
The audits carried out by Rx–360 are shared with the consortium's pharmaceutical manufacturer members, which regularly conduct their own independent audits of suppliers. The sharing of audit reports among industry is meant to reduce the number of repetitive audits hosted at a particular facility, allowing both pharmaceutical companies and suppliers to redirect resources toward higher risk suppliers and supply chains.
Rx-360 recently completed its first audit of a supplier member, Avantor Performance Materials, as part of a pilot program. This article describes Avantor's experience with the audit.
Avantor Performance Materials, formerly Mallinckrodt Baker, joined Rx–360 in 2009. Avantor is a global supplier of critical performance chemistries and materials, including bulk pharmaceutical excipients, GMP-manufactured aqueous solutions, and process chromatography media.
Based in Phillipsburg, NJ, and with sites around the world, Avantor has a strong focus on supply-chain security. For example, the company operates a Certified Excipient Distributor program that is designed to assure customers that a certified Avantor channel partner uses fully documented chain of custody and change-management procedures. In collaboration with its suppliers, Avantor is also working to regularly review supply-management procedures; provide enhanced tamper-evident features on products; improve transportation-security measures; and to use advanced track-and-trace technology.
Several companies volunteered to participate in Rx–360's pilot audit program. The consortium conducted an internal survey of its manufacturers to determine which companies were suitable for participation. The goal was to choose suppliers whose audit results would be applicable and relevant to as many manufacturers as possible (4). As a broad supplier to many of the consortium's members, Avantor was selected, among other companies, to participate in the pilot. Avantor was the first supplier to have availability to host an audit, which was conducted in April 2011.