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EMA Opens Consultation on GMP Non-Compliance Statement

Posted 03 April 2018 | By Zachary Brennan 

EMA Opens Consultation on GMP Non-Compliance Statement

What happens when a pharmaceutical manufacturing site is not compliant with good manufacturing practices (GMPs), but stopping the flow of certain products from that site to a member state would create shortages of life-saving medicines? That’s what the European Medicines Agency (EMA) is discussing in a new public consultation.

And this issue is not just one for Europe. In the US, lingering issues with Hospira manufacturing sites and many others have created dilemmas for FDA with regard to critical shortages of products. But under section 506C of the Federal Food, Drug, and Cosmetic Act, manufacturers are required to notify FDA of a permanent discontinuance or temporary interruption in manufacturing that is likely to lead to a meaningful supply disruption.

The aim of the EMA consultation, meanwhile, is to collect relevant information and help its GMP/Good distribution practice (GDP) Inspectors Working Group develop a risk-based approach for dealing with the supply of critical medicines in cases of serious GMP non-compliance, the agency said.

“In such cases, a statement of non-compliance is the outcome of the risk-assessment of GMP compliance of an inspected site,” EMA explained. “Following the principles of ICH Q9 the concerned member states subsequently have to decide how to manage the risk (recall, prohibition of supply, suspension of MIA etc.). Where those actions might lead to shortages of critical medicines in a particular member state of the European Union, the competent authority of that member state might decide to mitigate and accept the risk. However, this risk acceptance does not change the initial risk-assessment; the site will remain non-compliant until satisfactory corrective actions are taken.”

As part of the consultation, EMA is looking to revise relevant parts of the Compilation of Community Procedures on Inspections and Exchange of Information (CoCP) 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.”
As an immediate action, EMA said the template of the statement of non-compliance with GMP was updated, which will be followed by amending the relevant procedure in the CoCP, followed by revising 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.

EMA says comments on the proposed updated template (see first link below) should be submitted no later than 15 May 2018 by email to

Public consultation concerning the European Union template for good manufacturing practice (GMP) non-compliance statement

Reflection paper on medicinal product supply shortages caused by manufacturing/Good Manufacturing Practice Compliance problems

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