ICH Guideline Q9 on Quality Risk Management completed its path through the ICH process last November and is now awaiting implementation in the EU and Japan, having been published in the US in the Federal Register earlier this year.
Together with the already published ICH Guideline Q8 on Pharmaceutical Development and the in-development Q10 Guideline on Pharmaceutical Quality Systems, Q9 seeks to encourage the further development of science-based and risk-based approaches to quality.
Q9 seeks to focus the behaviours of industry and regulators on the two primary principles of risk management which it states as being:
- 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
As an aid to the application of Q9, the expert group that developed the Guideline has produced a briefing pack that, in a series of slide presentations, gives the context of the development of Guidelines Q8, 9 and 10 and gives specific advice on the application of the principles of the Q9 Guideline in the various stages of the quality process.
The progress of Q10 will be followed in this column - in the meantime the Guidelines Q8 and Q9 together with the briefing pack for Q9 can be found on the ICH website at www.ich.org