ICH Steering Committee meeting adopts new pharmaceutical guidelines

At its export working groups held earlier this month in Brussels, Belgium, the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Steering Committee highlighted the progress made in the area of pharmaceutical quality and manufacturing.

The Steering Committee adopted for consultation a new guideline, Pharmaceutical Quality Systems (Q10) which will complement existing Good Manufacturing Practices with modern quality systems elements.

This complements the recently-adopted guidelines on Pharmaceutical Development (Q8), which describes what 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, these guidelines form the foundation for a modern risk-based approach to pharmaceutical quality and manufacturing, says the ICH.