Spring Intro 2023

28/03/2023

ICH Q12 Lifecycle Management and Established Conditions

ICH Q12 aims to facilitate post-approval CMC changes in an efficient manner (currently at Step 1 in ICH process) Introduces the concept of “Established Conditions” – i.e. the CTD sections of the dossier (or specific content within a CTD section) that constitute a regulatory commitment Aims to define an appropriate level of detail in a submission that is sufficient for product assessment Goal – to enable a harmonised approach to post-approval change reporting and encourage technical progress. Avoid the need for “spurious” CMC submissions Also includes discussion on post-approval change protocols, incorporate quality system elements to submission

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3.2.P Drug Product 3.2.P.4 Control of excipients

P.4.1 Specifications

P.4.2 Analytical procedures

P.4.3 Validation of analytical procedures

P.4.4 Justification of specifications

P.4.5 Excipients of human or animal origin

P.4.6 Novel excipients

Full details included in 3.2.A.3

The Organisation for Professionals in Regulatory Affairs

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