Guidance for Applicants/MAHs Involved in GMP and GCP Inspections Coordinated by EMA

On 2 April 2022 the EMA published guidance for applicants/MAHs involved in GMP and GCP inspections.

These GMP and GCP inspections are requested by the Committee for Medicinal Products for Human Use (CHMP) in order to verify compliance with Good Manufacturing Practice of sites responsible for the manufacture of centrally authorized products and to verify compliance with Good Clinical Practice for centrally authorized products.

The details of each of the inspections adopted by the Committee(s), including the contact details of the persons in the inspection services who will be involved can be found in the IRIS Industry portal.

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