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This document provides guidance for FDA inspectors conducting inspections of foreign pharmaceutical manufacturers. It outlines that the number of these inspections has increased in recent years due to growth in pre-approval inspections and other routine activities. To effectively manage this resource-intensive program, consistency and uniformity are crucial. The guidance establishes procedures for inspection teams to prepare in advance of trips by reviewing background documents and communicating with FDA centers and offices. It describes the roles of different FDA branches and centers in coordinating these activities and managing the overall foreign inspection program.
This document provides guidance for FDA inspectors conducting inspections of foreign pharmaceutical manufacturers. It outlines that the number of these inspections has increased in recent ye…