Tablets & Capsules

TC1019

Issue link: https://www.e-digitaleditions.com/i/1173734

Contents of this Issue

Navigation

Page 15 of 67

14 October 2019 Tablets & Capsules tation review evaluates the quality of the excipient and the manufacturing process from start to finish, providing drug product manufacturers with a more standardized means of qualifying their suppliers on an annual basis. It is important to note that, according to FDA regulatory requirements, regardless 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 resources to help with excipient supply and testing issues, it is ulti- mately the responsibility of all drug manufacturers to confirm that their products comply with appropriate cGMP requirements to safeguard patient health. T&C References 1. w w w.fda.gov/dr ugs/news-events-human-dr ugs/ cder-conversation-assuring-drug-quality-around-globe. 2. w w w.fd a.gov/reg ulator y-infor mation /sear ch- fda-guidance-documents/testing-glycerin-diethylene- glycol. 3. www.fda.gov/media/86193/download. John Giannone is senior director, strategic marketing and program operations (SMPO) for excipients; Michael Rashed is marketing director, SMPO, for excipients; Peter Claise is marketing director, foods and excipients programs, SMPO; and Doug Podolsky is a technical writer at USP (301 881 0666, www.usp.org). USP is a private, independent, non- profit organization founded in 1820 that develops scientific standards to help ensure the quality and safety of medicines, dietary supplements, and foods. For more information about USP IVP-E, contact John Atwater (301 816 8529, jba@usp.org). For more information about USP's proposed general chapter on supplier qualification, contact Catherine Sheehan (301 816 8262, cxs@usp.org). Acid Resistant Vegetable Capsules ) u . u, ' . AN EXCELLENT CHOICE FOR DELIVERY OF ACID-SENSITIVE ACTIVE INGREDIENTS . <> . BioCaps Enterprises, Inc. www.biocaps.net • info@biocaps.net US Patent 9452141 SSW Booth# 2153

Articles in this issue

Links on this page

Archives of this issue

view archives of Tablets & Capsules - TC1019