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GHTF to release two guidances on inspections

This article was originally published in The Silver Sheet

Executive Summary

A new "N33" guidance document that provides a framework for auditors writing reports after conducting a quality systems inspection will soon be released by the Global Harmonization Task Force's (GHTF) Study Group 4. "This document gives us a common format to work from so that if I at FDA am at my desk and I get 50 of these reports to read from around the world ... I know that I'm coming up on the same information in the same format" as fellow auditors in different countries, said Jan Welch, a consumer safety officer in CDRH's Office of Compliance, and secretary of the study group. She said a draft revision of "N28" - a guidance document on facility inspections that takes newer versions of global standards into account - will be released at the same time. "We very much are interested in getting comments from all of you ... on this document," Welch told GHTF participants

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