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FDA QUALITY INITIATIVE TWO-YEAR ANNIVERSARY

This article was originally published in The Gold Sheet

Executive Summary

...marks a shift in focus from assessment and design to implementation. With the conceptual framework in place, FDA and industry are now turning their attention to putting principles into practice. In late September, FDA released a detailed report and a bolus of related documents intended to drive the initiative forward. Among the significant GMP-related issues addressed in the documents are: • innovation and continuous improvement • risk-based inspections • warning letter assessment • Part 11 • the pharmaceutical inspectorate curriculum • quality system implementation • GMP harmonization • process analytical technology • aseptic processing • combination product GMPs, and • clinical trial computer systems. [A discussion by CDER Office of Compliance Director David Horowitz of the initiative’s progress and future direction is included].

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