First published in: Pharm. Ind. 72, Nr. 2, 242-247 (2010), Editio Cantor Verlag Aulendorf (Germany)

GMP for Active Pharmaceutical Ingredients: Judging the Audit Quality from the Audit Report

Dr. Stefan Kettelhoit, blue inspection body GmbH, Münster (Germany)

This article covers necessary requirements for API audit reports aiming to demonstrate that the GMP status of a supplier has been reasonably and comprehensibly assessed during the on-site audit. Based upon the EMEA “GMP Inspection Report – Community Format” a proposal has been developed for the unambiguous, understandable and most importantly complete coverage of audit contents in the audit report.  Click here to view entire article...