Draft ICH Q10 guideline adopted at Step 2 for consultation

The much awaited International Conference on Harmonisation (ICH) Q10 guideline entitled 'Pharmaceutical Quality System' reached Step 2 of the ICH process in early May.

At this stage, the guideline embodying the scientific consensus of the ICH partners leaves the ICH process and becomes the subject of normal wide-ranging regulatory consultation within the three regions (the EU, Japan and the US). In the EU it will be published as a draft CHMP Guideline.

This guideline complements the already adopted guidelines on 'Pharmaceutical Development' (Q8), which describes what information should be submitted to a regulatory authority, and 'Quality Risk Management' (Q9), which provides principles and examples of quality risk management that can be applied to all aspects of development and manufacture of a medicinal product, including aspects of inspection.

Together, the three guidelines form the foundation for a modern risk-based approach to pharmaceutical quality and manufacturing. The Q8 and Q9 guidelines have already been discussed in this column and the regulatory procedures in the various ICH regions are evolving to incorporate the concepts enshrined in this already published guidance.

The stated aim of the ICH Q10 guideline is that its implementation throughout the product cycle should facilitate innovation and continual improvement and strengthen the link between pharmaceutical development and manufacturing activities. The new draft guideline seeks to demonstrate the support of industry and regulatory authorities of an effective pharmaceutical quality system to enhance the quality and availability of medicines around the world in the interest of public health.

Depending on the progress and outcome of the Step 3 consultation exercise the draft guideline will progress to adoption by ICH (Step 4) and then to eventual implementation by the member regulatory agencies (Step 5). The progress of this process will be reviewed in this column.