ICH Q9 document on Quality Risk Management: The text of this document, formerly Annex 20, remains optional and provides examples of the processes and applications of Quality Risk Management. Document.pdf  |
| ICH Q10 document on Quality Risk Management: The content of ICH Q10 that is additional to the scope of GMP is optional. Its use should facilitate innovation, continual improvement and strengthen the link between pharmaceutical development and manufacturing activities. Document.pdf |
