EMA opens consultation on GMP non-compliance statement

The purpose of the consultation from the European Medicines Agency (EMA) is to collect relevant information from stakeholders to help the Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) Inspectors Working Group. The aim is to develop an effective and harmonised risk-based approach for dealing with the supply of critical medicines in the case of serious GMP non-compliance.

The EMA states that, in such cases, a statement of non-compliance is the outcome of the risk-assessment of GMP compliance of an inspected site. “Following the principles of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q9, the concerned member states subsequently have to decide how to manage the risk”. Where actions such as recall or prohibition of supply may lead to shortages of critical medicines in a particular member state of the European Union (EU), the competent authority of that member state may decide to mitigate and accept the risk. However, this risk acceptance does not change the initial risk-assessment and thus the site will remain non-compliant until satisfactory corrective actions are taken.

In order to enhance the procedure for dealing with serious GMP non-compliance, the relevant parts of the Compilation of Community Procedures on Inspections and Exchange of Information (CoCP) shall be revised 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.

As an immediate action the template of the statement of non-compliance with GMP has been updated. The EMA states that this will be followed by amending the relevant procedure in the CoCP, followed by the revision of the templates of the statements of non-compliance with Good Distribution Practice and the statement of non-compliance with Good Distribution Practice of a distributor of active substances for use as starting materials in medicinal products for human use.

To view the public consultation document concerning the EU template for GMP non-compliance statement, please click here.

Comments on the proposed updated template (please see pages 3 and 4 of the document) should be submitted no later than 15 May 2018 by email to ADM-GMDP@ema.europa.eu