EudraGMDP is an openly accessible EU database
which houses manufacturing and import authorisations, registration of active substance manufacturers, GMP certificates, and non-compliance statements for active substance products manufactured or imported within its borders.
Following inspection, EU competent authorities issue either a GMP certificate or non-compliance statement, which are then entered in EudraGMDP database.
GMP/GDP Inspectors Working Group EMA serves as host and secretariat to the GMP/GDP Inspectors Working Group comprised of senior inspectors appointed by all EEA competent authorities, convened to meet four times annually at EMA.
European Commission officials, as well as observers from EU accession countries and mutual recognition partner authorities; as well as representatives of the European Directorate for Quality Medicines and Healthcare as well as World Health Organization; regularly attend working group meetings.
This group provides an avenue for discussion of issues of common concern such as:
Updates or amendments to EU GMP guidelines; compilation of Union procedures; and harmonized interpretation of GMP requirements and associated regulations are key components.
Compilation of Union Procedures
EMA keeps an up-to-date compilation of GMP and good distribution practice (GDP) inspection-related forms agreed by all Member States, to facilitate cooperation among EU member states as well as harmonisation and exchange of inspection data.
It provides the foundation for national procedures that form part of national inspectorates’ quality systems:
List Item (PDF/2.41 MB), Adopted on 2 August 2008 and last revised 20 April 2022 by the EU Executive Agency and EU National Authorities as follows. Legal Effective Date is 26 July 2022 (EMA/INS/428126/2021 Rev.18 Corr).
EMA has released Word and PDF versions of certain templates to facilitate inspection agencies’ work.
Rapid Alert Notification of Quality Defect/Recall, followed up with non-urgent information / updates about quality defects; Follow-up on quality defect/recall; Good Manufacturing Practice Inspection Report in Community Format
Revamp of template for serious GMP non-compliance
EMA’s GMP/GDP Inspectors Working Group is discussing actions required when an inspection identifies manufacturing sites which fail to abide by GMP, specifically when such noncompliance could lead to shortages of crucial medicines. As part of its public consultation for 2018 on updated templates for non-compliance statements.
PDF icon Public consultation on an EU template for GMP non-compliance statements for pharmaceutical starting materials
Inspections under the Plasma Master File (PMF) certification procedure
For products derived from blood or plasma, EMA is responsible for organizing inspections at establishments that collect, test, process, store and distribute their blood products under PMF certification procedure.
For more information regarding PMF certification process, see Plasma master files.
https://www.ema.europa.eu/en/human-regulatory/overview/plasma-master-file-pmf-certification
Inspection of Vaccine Antigen Master File (VAMF)
EMA is responsible for managing inspections at vaccine antigen manufacturing sites under the VAMF certification procedure.
For more information about the VAMF certification procedure, see Vaccine antigens.
Mutual Recognition Agreements The EU has signed several mutual recognition agreements on GMP inspections between regulatory bodies outside the EU and EU authorities. This allows both bodies to:
These agreements allow companies to rely on each other’s GMP inspections; waive batch testing of products entering their territories; share information on inspections and quality defects; and share inspection results and quality defects information with each other. Each agreement varies in scope. For more information, see EudraGMDP Database; GMP/GDP Inspectors Working Group and Mutual Recognition Agreements as well as Good Manufacturing Practice.
International Collaboration Agreement.
https://health.ec.europa.eu/system/files/2022-08/20220825_gmp-an1_en_0.pdf
