Industry feedback on ICH Q12: implementation considerations for FDA-regulated products

The aim of ICH Q12 is clearly stated as a framework to facilitate the management of post-approval CMC changes. The biopharmaceutical industry through these comments commends the agency on leading the way to the implementation of ICH Q12. The BioPhorum comments are heavily influenced by the principle of simplification, which is why our views sometimes differ from the draft guideline.

Building product registration on knowledge and understanding, and what has an impact on product quality is what BioPhorum and its member organizations aim to achieve through their collaboration. ICH Q12 and the establishment of the conditions that ensure product quality is therefore completely aligned with our principles. This document reviews the draft guidelines and makes recommendations based on industry feedback. This feedback is based on CMC biopharmaceutical experts from within the BioPhorum membership.

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BioPhorum response to FDA ICH Q12 September 2021.pdf
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