Concept paper on revising chapter 8 of the European Commission guide to good manufacturing practice to introduce risk-based concepts and to provide for more effective investigations, and corrective actions and preventive actions

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Download document Concept paper on revising chapter 8 of the European Commission guide to good manufacturing practice to introduce risk-based concepts and to provide for more effective investigations, and corrective actions and preventive actions
Reference number EMA/INS/GMP/263759/2011 Rev. 1
Status draft: consultation closed
First published 12/04/2011
Last updated 14/06/2011

Summary

The proposed guideline will replace the current version of chapter 8.