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The GMP/GDP Inspectors Working Group is 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.
In this context, EMA has just launched a public consultation on an updated EU GMP non-compliance statement template.
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.
Please see link document below. If you have any comments please let me, Janet Halliday, have them by Wed 9th May.
https://www.rpharms.com/Portals/0/Groups/37/GMP Inspections Consultation.pdf?ver=2018-04-09-113739-567
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