CRED Getting the CMC Dossier Right 2024

28/08/2024

ICH Q11: Traditional vs. Enhanced [2]

Enhanced approach uses many data points to establish a rate equation to determine relationship of time and water content

Area below the line is the proposed design space

Traditional Approach

Proven Acceptable Range can be established with one experiment but flexibility is limited

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ICH Q11: Control Strategy

A control strategy should ensure that each drug substance CQA is within the appropriate range, limit, or distribution to assure drug substance quality ▪ The drug substance specification is one part of the overall control strategy and not all CQAs need to be included in the drug

substance specification. CQAs can be ▪ (1) included on the DS specification

▪ (2) included on the DS specification and confirmed through upstream controls (e.g. parameters, IPCs, intermediate specs) ▪ (3) not included on the DS specification but ensured through upstream controls ▪ Controls on starting materials, reagents, intermediates, IPCs ▪ Controls on process parameters ▪ (4) not included on the DS specification but ensured by the process ▪ Controls implicit in the design of the manufacturing process (e.g. order or addition or reagents, presence of purification steps)

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