Introduction

Workshops were intended to provide opportunities for:

  • Both API (small and large molecules) and drug (medicinal) product as well as
    - Industry involved in development, manufacturing, quality, regulatory affairs; and
    - Regulators responsible for dossier assessments and GMP inspections.
  • A comprehensive training on the integrated implementation of Q8, Q9 and Q10 in pharmaceutical development and manufacturing, regulatory assessment, scale up, implementation into commercial manufacturing operations and GMP-inspection. A specific case study was used demonstrating opportunities when using the combination of Q8, Q9, Q10.
  • A comprehensive training on regulatory aspects (regulatory expectations, dossier preparation, assessment and GMP-inspections) in addition to technical development and manufacturing details.
  • All attendees actively participated in all workshop tracks with key messages covering development, regulatory assessment, manufacturing implementation and GMP-inspection.

The training was carried out in the 3 regions in a workshop format lead by ICH faculty responsible for the development and implementation of ICH Q8, Q9 and Q10. The workshop attendees participated actively in discussions and developing solution to implementation challenges.

The workshop material is intended to be used for internal training purposes for industry and regulators.

Disclaimer: The information within the presentations is based on the ICH Q-IWG members’ expertise and experience, and represents the views of the ICH Q-IWG members for the purposes of a training workshop.