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SUPAC-IR guidance does not eliminate site inspection requirements, FDA reminds industry.

This article was originally published in The Tan Sheet

Executive Summary

SUPAC-IR GUIDANCE DOES NOT ELIMINATE SITE CHANGE INSPECTIONS, FDA emphasizes in an April 11 letter to industry on the agency's implemen-tation of its guidance on Scale-Up and Post-Approval Changes for Immediate Release Solid Oral Dosage Forms. The guidance, finalized in November, "does not eliminate inspection requirements for site changes, nor requirements that firms have adequate process validation to support all changes," the letter states.
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