On August 31, 2022 the EMA updated its guidance "Guidance for applicants/MAHs involved in GMP, GCP and GVP inspections coordinated by EMA".
GMP inspections:
These inspections are requested by the Committee for Medicinal Products for Human Use in order to verify compliance with Good Manufacturing practices of sites responsible for the manufacture of centrally authorised 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.
The inspection fees are payable in connection with this inspection and an invoice for this will be sent to Applicants/MAHs by the EMA. For more information on fees, click this link Fees website.
GCP inspections:
These inspections are requested by the Committee for Medicinal Products for Human Use (CHMP) in order to verify compliance with Good Clinical Practice for centrally authorised products.
Applicants/MAHs should ensure that they have identified all trial documentation and its location that comprises the TMF and determined how this documentation will be made readily available to the inspectors.
Click this LINK to know more about the documents and information that needs to be provided via the IRIS Industry portal.
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