Summary

ICH Q12 on Pharmaceutical Product Lifecycle Management was issued for public consultation

ICH Q12 Draft Guideline provides the framework to facilitate the management of post-approval CMC changes in a predictable and efficient manner.  Use of the tools and enablers outlined in the guideline should enhance industry’s ability to manage many CMC changes through the firm’s Pharmaceutical Quality System with less regulatory oversight prior to implementation.

Annex

Draft Guideline

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