ICH Q8-10 IWG Making Adjustments Based on Estonia Workshop and Follow-up ICH Meeting

The ICH Q8-10 Implementation Working Group (IWG) has concluded, based on its industry/regulator workshop in Tallinn, Estonia in early June and the IWG’s internal meeting the following week, that refinement of the training model used in the workshop, additional Q&As, and further evaluation of the other ICH quality guidelines for inclusion of Q8-10 principles are needed.

Future areas of focus for the IWG will include examining the remaining technical and regulatory gaps to determine the need for development of further training – potentially including non-ICH regions – and how to proceed with assessment of the other ICH quality guidelines for consistency with quality-by-design principles.

The IWG workshop, co-sponsored by PDA and ISPE, was attended by 240 participants from 34 countries, with 100 assessors and inspectors from 32 different health authorities and 140 industry experts representing 45 companies.  The ratio of assessors to inspectors among the regulators was about three-to-one.

The workshop began with four plenary presentations on the development, assessment, manufacturing, and inspection components of Q8-10 implementation.  A mock case study was developed for the workshop to elucidate the application of QbD in these phases of the product lifecycle.

With the case study as an anchor for the discussions, breakout sessions followed on design space, control strategy, quality risk management, and pharmaceutical quality systems through which the participants rotated.

[More on the Tallinn workshop and subsequent IWG discussions is provided for subscribers here.]