Understanding ICH Q8, 9 and 10

The International Conference on Harmonisation is a collection of the world’s leading regulatory authorities. Sitting on the ICH panel include representatives of the EU, USA and Japan plus other countries and areas.

Historically the ICH have produced guidelines that support GMP and marketing applications for new products. In the past 10 years they have produced 3 guidelines that have ramifications for Pharmaceutical Quality Management. These are called ICH Q 8, 9 and 10. The “Q” is because they belong in their family of Quality guidelines, rather than the ICH’s Safety or Efficacy guidelines.

Of particular note to us will be ICH Q10 – Pharmaceutical Quality Systems. For the sake of completeness however we will quickly cover the principles of ICH Q8 and Q9 first.