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DRUG MANUFACTURING EQUIPMENT CHANGES DO NOT REQUIRE PRIOR FDA APPROVAL

This article was originally published in The Tan Sheet

Executive Summary

DRUG MANUFACTURING EQUIPMENT CHANGES DO NOT REQUIRE PRIOR FDA APPROVAL when changing "to equipment of the same design and operating principles from the same or a different manufacturer" or when changing "to the same equipment with a different capacity," provided that "the capacity should not exceed 10 times the test batch size," the agency explained. In a draft guidance on manufacturing supplements, FDA noted that such changes would "ordinarily" require only description in a company's annual report. The draft guideline, which applies only to non-sterile drug products, was published in the Dec. 12 Federal Register.
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