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SUPPLIER AUDITING PROGRAMS

This article was originally published in The Gold Sheet

Executive Summary

...are being developed covering excipient manufacturers and computer vendors as part of a pharmaceutical industry push to broaden quality assurance. Suppliers and users are cooperating on the two auditing programs designed to standardize auditing practices and reduce the overall resource burden. To complement its new auditing program, the International Pharmaceutical Excipients Council is developing a series of excipient guides based on its GMP document that will address -- auditing manufacturers and distributors -- handling manufacturing changes -- profiling impurities n n formulating certificates of analysis -- and developing specifications. The association PDA is launching a "shared" auditing program for computer suppliers similar to the IPEC effort. A new guide on cooperative manufacturing arrangements from CBER will expand the use of contract manufacturing and create new communication and auditing challenges for participating biologics companies. [A discussion by a DuPont official of the firm’s auditing program for foreign contract manufacturers begins on p. 15.]
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