Current GMP News and Events. With this newsletter we would like to inform you about the following current GMP trends. Your ECA Team

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ECA GMP Newsletter

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With this newsletter we would like to inform you about the following current GMP trends.

Your ECA Team


MRA Countdown: 10, 6, 4, 2, ...

The FDA has confirmed two other EU Member States to carry out GMP inspections at a level equivalent to that of the US. Only two states are still missing to implement the Mutual Recognition Agreement (MRA) between the FDA and the EU.


Webinar: WFI Production with Membrane Technology

 

The Monograph for Highly Purified Water (HPW) will be deleted from the European Pharmacopeia in April 2019. But what happens to existing HPW systems. Can these systems be used for manufacturing of cold Water for Injection (WFI)? The GMP regulators say no: additional measures have to be taken, to prove that WFI manufactured with membrane processes is as safe as WFI by distillation. Learn more about the future of non-distillation methods for WFI production in the webinar on June 25, 14.00 - 15.30 h.


FDA Blockchain Pilot

The US FDA has selected four companies to participate in a pilot evaluating blockchain technology to enhance supply chain security.


GDP in Switzerland

 

Learn and discuss how to manage your distribution activities in Switzerland in compliance with EU-GDP - on 3 September 2019. Please see the programme for further information.


ECA GMP News Service on Twitter

Get the latest GMP trends quickly and easily anytime and anywhere - with the ECA's service on Twitter.


Reconstruction and Upgrading of GMP Facilities

 

The number of remodelling projects is higher than the number of greenfield projects. The reasons may be strategic or political, but one main aspect is quite often overseen: production has to continue during construction. How this can be achieved in a GMP-compliant way is the main topic of this course from 10-11 September. The training also includes a workshop on the real-life remodelling project of CSL Behring. Please see the programme for further information.


In case you missed the previous GMP Newsletter, here are the news from last week:

For further recent news please go here.


Forthcoming GMP/FDA Events

Here you will find an updated overview of forthcoming education courses and conferences.

 

Yours sincerely,

The ECA Academy


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