EMA opens public consultation on GMP non-compliance template

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EMA opens public consultation on GMP non-compliance template

Home/Guidelines | Posted 13/04/2018 0 Post your comment

The European Medicines Agency (EMA) announced on 3 April 2018 that it had opened a public consultation concerning the European Union (EU) template for good manufacturing practice (GMP) non-compliance statement.

EMA is concerned about what to do when a drug production site is not compliant with GMP but disrupting the supply could lead to shortages of essential medicines.

The aim of the public consultation is therefore to collect relevant information from stakeholders to help the GMP/Good distribution practice (GDP) Inspectors Working Group to develop an effective and harmonized risk-based approach for dealing with the supply of critical medicines in case of serious GMP non-compliance. This will amend the compilation of community procedures (CoCP) and exchange of information.

Public consultation concerning the EU template for GMP non-compliance statement
Date: 26 March 2018
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2018/04/WC500246646.pdf

The agency wants to revise the relevant parts of the 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 revision of the CoCP will then be followed by revision of the templates of the statements of non-compliance with GDP and the statement of non-compliance with GDP of a distributor of active substances for use as starting materials in medicinal products for human use.

Comments on the proposed updated template should be submitted no later than 15 May 2018 by email to ADM‑GMDP@ema.europa.eu

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Source: EMA