Quality by design: questions and answers

This content applies to human and veterinary medicines.

This page lists questions that applicants and marketing-authorisation holders may have on quality by design and process analytical technology (PAT).

Most of these questions arose in connection with the publication of quality guidelines by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The quality-by-design approach can be adopted both for human and for veterinary medicines.

For each question, the date of publication is given.

For more information and documents, see quality by design.

Design space


Validation strategy


Cooperation between assessors and inspectors when real-time release testing (RTRT) is applied


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