EMEA Issues SOP on Coordination of Pre-Approval GxP Inspections

GMP News
28 June 2007

EMEA Issues SOP on Coordination of Pre-Approval GxP Inspections

An SOP has been issued by the European Medicines Agency (EMEA) describing "processes used for Inspection Co-ordination in the routine review of applications, preparation and processing of inspection requests, and co-ordination and reporting of inspections in human and veterinary, when appropriate, applications for marketing authorisations under the centralised procedure."

This SOP was developed to harmonise practices across all types of inspections and integrates previous SOPs for the coordination of GMP inspections (SOP-INSP-2003), GCP (SOP-INSP-2004) and GLP (SOP-INSP-2008) in this single SOP.

As the authority points out, it "applies to all pre-approval inspections that may be requested by CHMP and/or CVMP during the evaluation phase of an application for a medicinal product under the centralised system. It therefore covers GMP, GCP and GLP inspections."

The SOPs includes various definitions and explains all relevant acronyms and provides Process Map(s)/ Flow Chart(s) to visualise and explain the overall process.

The SOP can be found here: http://www.emea.europa.eu/Inspections/docs/SOP2019.pdf

Learn more about inspections, audits and related topics in the following ECA course:

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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