The document discusses inspections related to the implementation of ICH Q8, Q9, and Q10 guidelines. It outlines the aims, types, and focus of inspections. Key points include:
- Inspections evaluate commercial manufacturing capability and quality systems. Pre-approval inspections additionally evaluate submitted data authenticity.
- Inspections focus on implementing control strategies, design spaces, change management, and models for quality predictions and release.
- Case studies are used to demonstrate evaluating risks, variables, and implementing marketing authorization requirements at manufacturing sites.
1. International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use
Implementation of ICH Q8, Q9, Q10
Inspection