ICH Q9

Question 1

Provide a summary of ICH Q9

Answer 1

The intention of ICH Q9 is to focus the behaviours of industry and regulatory authorities on the two primary principles of Quality Risk Management, which are:
The evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient;
And
The level of effort, formality and documentation of the Quality Risk Management process should be commensurate with the level of risk.
ICH Q9 provides principles and a framework for decision making
It is a “guidance” not an “SOP” which is Simple, Flexible and Not mandatory

Structure of ICH Q9
Main body explains the “What?”
Annex I give ideas on the “How?”- Tool listed
Annex II give ideas on the “Where?”- to use
Pharmaceutical Development (ICH Q8) and Quality Systems (ICH Q10) will facilitate the use of Q9