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ICH: Agenda Papers for the upcoming ICH SC Meeting available
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News about GMP/cGMP

2015-06-01

ICH: Agenda Papers for the upcoming ICH SC Meeting available

The ICH Steering Committee (SC) will meet in Fukuoka, Japan from 6 to 11 June to discuss ongoing harmonisation activities. One item on the agenda is the development of the ICH Q12 Guideline on Lifecycle Management.

 

This new ICH Guideline will focus on the harmonisation of change management, leading to better availability and reliability of the supply by enabling companies and regulators to manage Chemistry Manufacturing and Controls changes in a more transparent and efficient manner across the product lifecycle. The Q12 Guideline will cover the following aspects: regulatory dossiers, pharmaceutical quality system, and the post-approval change management plans and protocols.

The respective Expert Working Group will have a face-to-face meeting, June 7-11, 2015, to review initial drafts of guideline chapters, discuss major issues and concerns, and develop guideline version. A Step 2 document is anticipated to be finalised in the second quarter of 2016.

Source:

ICH - News

ICH Steering Committee - Agenda

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