Development and Manufacturing of APIs: Final ICH Q11 Document Published!

In June 2011, the ICH published Guideline Q11 on development and manufacture of chemical entities and biotechnological/biological drug substances (see also our News from 21 June 2011). Almost one year later - at the beginning of May - the final document was released.

The guideline describes the principles and approaches regarding the development of APIs. It also refers to the ICH Q8, Q9 and Q10 guidelines. Moreover it provides guidance on what information should be provided for authorisation procedures in CTD sections 3.2.S.2.2 - 3.2.S.2.6.

The final ICH Q11 guideline contains several textual revisions. The content of chapter 3.1.6 "Design Space" has been considerably extended compared to the previous version. The concept of Design Space is clearly defined and the impact of critical quality attributes (CQAs) is described. This chapter addresses the particular situation regarding biotechnological drug substances. Factors like process variability and drug substance complexity (e.g. post-translational modifications) may affect residual risk (e.g. potential for unexpected changes to CQAs based on uncertainties related to scale sensitivity) which remains after approval of the design space. The applicant should provide proposals on how movements within a design space will be managed post approval. The proposal should indicate how (e.g. via an appropriate control strategy and characterisation methods) product quality can be ensured following movement within the approved design space. This situation is more likely to appear with highly complex biotechnological drugs substances as with chemical entities.
A comparison of both documents may provide helpful information on what modifications have been made. A comparative document between the ICH Q11 Guideline draft version (Draft Consensus Guideline, Step 2) and the finalised version (Step 4) is available for ECA members in the ECA webpage's members area.

Note: The ECA Conference "ICH Q11 Training Course" on 20 - 21 November 2012 in Budapest will present all the significant aspects of the new guideline.

Dr Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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