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usp.org US Pharmacopeia Proposed general chapter on supplier qualification. To help further support managing complex supplier net- works and their effect on quality, USP is working with stakeholders to develop an informational general chapter on supplier qualification throughout the pharmaceutical supply chain. This proposal, if approved by the expert committee, will provide standardized, robust solutions for supply chain partner management and development. USP is also developing a toolkit of solutions to provide guid- ance and help minimize risk to product quality caused by insufficient supply chain development and management. USP and other stakeholders recognized the need for this general chapter due to research that suggested supply chain failures are not solely caused by suppliers but may be related to risks either induced by the drug product manufacturers or that the manufacturers could have avoided. The direct impact of this paradigm shift is that it refocuses resources from micromanaging suppliers to improving internal processes that can affect relationships and supplier performance. It should enable firms to take ownership of the failure modes impacting supply chain integrity and develop solutions that will help to reduce product quality risks. It will also promote understanding of critical root causes that affect supply chain integrity and, therefore, could create risks to product quality. The proposed general chapter is now proceeding through USP's public standards-setting process, with participa- tion drawn from industry and regulatory professionals, and opportunities for public comment through USP's Pharmacopeial Forum (PF). USP will announce when the References 1. www.fda.gov/drugs/news-events-human- drugs/cder-conversation-assuring-drug-quali- ty-around-globe. 2. www.fda.gov/regulatory-information/ search-fda-guidance-documents/testing-glycerin- di-ethylene-glycol. 3. www.fda.gov/media/86193/download. proposed chapter appears in PF. Publication in USP-NF is expected by early 2021. Excipient verification program. The USP Ingredient Verifi- cation Program for Excipients (USP IVP-E) provides inde- pendent third-party verification of the quality of ingredi- ents and is designed to help drug product manufacturers qualify their excipient suppliers and verify COAs. The pro- gram includes annual GMP facility audits, annual random lot testing to help ensure that materials comply with their specifications, and quality control and manufacturing doc- umentation reviews that help manufacturers routinely veri- fy the information on excipient suppliers' COAs. The program goes beyond a paper or on-site GMP audit, evaluating not only what the supplier is doing to control quality and how those controls are being implemented, but also why those are the correct controls to help ensure product quality. The USP IVP-E GMP quality control and manufacturing product documentation review evaluates the quality of the excipient and the manufacturing pro- cess from start to finish, providing drug product manu- facturers with a more standardized means of qualifying their suppliers on an annual basis. It is important to note that, according to FDA regulatory requirements, regard- less of whatever supplier validation program is in place, drug manufacturers are still required to conduct at least one test to verify the identity of each component of a drug product, including excipients. Although drug manufacturers can use USP's resourc- es to help with excipient supply and testing issues, it is ultimately the responsibility of all drug manufacturers to confirm that their products comply with appropriate cGMP requirements to safeguard patient health. John Giannone is senior director, strategic marketing and program operations (SMPO) for excipients; Michael Rashed is director, non-pharma programs; Peter Claise is director of product management; and Doug Podolsky is a technical writer at USP (301 881 0666, www.usp.org). For more information on USP's Ingredient Verification Program for Excipients, visit https://www.usp.org/ verification-services/excipient-ingredient-verification 8 The USP Ingredient Verification Program for Excipients provides independent third-party verification of the quality of ingredients and is designed to help drug product manufacturers qualify their excipient suppliers and verify COAs.