ICH Q10 Moves to Final Stage: International Adoption

Portland, OR (June 5)-The steering committee of the International Conference on Harmonization and its expert working groups adopted Quality Guideline Q10 “Quality Systems” last week at a meeting in Portland, Oregon. The adoption represents the final stage of the harmonization process, which means that all parties to ICH (the US, Europe, and Japan) have reached scientific consensus on the technical issues of the guideline’s text and agreed to fully implement the guideline through their individual regulatory bodies.

Q10 was in Step 3 (the consultation and comment period) from May 2007 until last week, the ICH parties finalized the guideline’s concept in late 2005.

Q10 incorporates the concepts behind ICH Q8 “Pharmaceutical Development” and ICH Q9 “Quality Risk Management” by providing a model for a pharmaceutical quality system that can be implemented throughout a product life cycle. Q10 is meant to complement and add to current good manufacturing practices but, as a guideline, is not enforceable. The overall goal, according to the Q10 business plan, is to facilitate innovation and continual improvement and strengthen the link between pharmaceutical development and manufacturing activities.