DRUG MANUFACTURING EQUIPMENT CHANGES DO NOT REQUIRE PRIOR APPROVAL

Executive Summary

DRUG MANUFACTURING EQUIPMENT CHANGES DO NOT REQUIRE PRIOR APPROVAL from FDA 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a different capacity" provided that "the capacity should not exceed 10 times the test batch size," FDA explains in a draft guidance on manufacturing supplements. 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.