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Tablets & Capsules October 2019 13 turers verify the quality of theirexcipient supply. These specimens have well-defined physical and chemical properties and when used in conjunction with the monograph help ensure the identity, strength, quality, and purity of materials. USP encourages manufacturers to provide infor- mation for the development of new monographs or to donate reference standard candidate materials. 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 sup- ply chain failures are not solely caused by suppliers but may be related to risks either induced by the drug prod- uct 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 participation drawn from industry and regulatory pro- fessionals, and opportunities for public comment through USP's Pharmacopeial Forum (PF). USP will announce when the proposed chapter appears in PF. Publication in USP– NF is expected by early 2021. Excipient verification program. The USP Ingredi- ent Verification Program for Excipients (USP IVP-E) provides independent third-party verification of the quality of ingredients and is designed to help drug prod- uct manufacturers qualify their excipient suppliers and verify COAs. The program includes annual GMP facil- ity audits, annual random lot testing to help ensure that materials comply with their specifications, and quality control and manufacturing documentation reviews that help manufacturers routinely verify 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 imple- mented, but also why those are the correct controls to help ensure product quality. The USP IVP-E GMP quality control and manufacturing product documen- info@ artnett.com info@ artnett.com info@ artnett.com info@ artnett.com info@ artnett.com info@ artnett.com info@ artnett.com info@ artnett.com info@ artnett.com info@ artnett.com info@ artnett.com info@ artnett.com info@ artnett.com info@ artnett.com 215-969-9190 info@ artnett.com info@ artnett.com info@ artnett.com info@ artnett.com 215-969-9190 215-969-9190 215-969-9190 215-969-9190