New EU Template for GMP Non-Compliance Statement

The GMP/GDP Inspectors Working Group at EMA is currently discussing actions required after an inspection concludes that a manufacturing site does not comply with GMP, specifically where this can lead to a shortage of critical medicines.

If a site receives a statement of non-compliance it does not necessarily mean the end of manufacturing. Based on ICH Q9 principles, the competent authorities and the concerned Member States of the European Union (EU) will have to decide how to manage the risk associated with the GMP non-compliance (e.g. recall, prohibition of supply, suspension of MIA etc.). In some cases these actions could lead to shortages of critical medicines in a particular Member State. If so, the competent authority of that Member State "might decide to mitigate and accept the risk". The initial risk-assessment will not be changed and the site will remain non-compliant.
In this context, the EMA has just launched a public consultation on an updated EU GMP non-compliance statement template and to revise parts of the Compilation of Community Procedures on Inspections and Exchange of Information (CoCP) "in order to enhance the procedure for dealing with serious GMP non-compliance by":

  • separating processes of risk assessment and risk control;
  • accelerating public release of non-compliance statements;
  • avoiding generation of conditioned GMP certificates along with non-compliance statements;
  • providing specific guidance for Qualified Persons to facilitate release batches of critical drug products.

The aim of the consultation is to collect relevant information from stakeholders to help the GMP/GDP Inspectors Working Group to develop an effective and harmonised risk-based approach for dealing with the supply of critical medicines in case of serious GMP non-compliance.
Stakeholders are invited to submit their comments by e-mail to: no later than 15 May 2018.

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