|
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
|
