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FDA's DRUG QUALITY INITIATIVE

This article was originally published in The Gold Sheet

Executive Summary

...hit its one year anniversary at full stride with new guidance documents, outside collaborations and review and inspection program changes emerging. In early September, the agency released draft guidances covering aseptic processing, dispute resolution, comparability protocols and process analytical technology, along with a final version of a guidance on Part 11. Having moved quickly through the FDA pipeline, the guidances are designed to push industry to take advantage of the advancing technology and quality science while reducing potential regulatory barriers. A specially-trained cadre of pharmaceutical investigators is among inspection program changes the agency is making to create more field/center consistency and help allay industry's regulatory concerns about making technology upgrades. [A discussion by CDER Office of Compliance Director David Horowitz of progress made during the first year of the drug quality initiative is included]
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