ICH Meets in Estonia

Last week, the steering committee and expert working groups (EWGs) of the International Conference on Harmonizaton (ICH) met in Tallinn, Estonia, to discuss progress on the ICH quality trio guidelines and other Step-4 documents.

The ICH Quality Implementation Working Group, which focuses on guidelines Q8 Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System, held its first training workshop during the meeting. The workshop focused on how to use design space, control strategy, and quality risk management, among other topics. Approximately 240 individuals, including inspectors, from 34 countries attended the workshop. Additional workshops will be held in Washington, DC, and in Tokyo, in October 2010.

ICH representatives also adopted Annexes 11 and 12 to the Q4B guideline titled Evaluation and Recommendation of Pharmacopoeial Text for Use in the ICH Regions to Step 4. The next phase, Step 5, requires each region to publish and implement the guideline. The annexes harmonize analytical procedures for capillary electrophoresis and sieving. Two additional Q4B annexes, Annex 13 on bulk and tapped density and Annex 14 on bacterial endotoxin, moved to Step 2, which means the six parties to ICH have reached consensus on a draft guideline.

Also of note, the Q3D EWG held its first official meeting to set limits on metal impurities in drug products and ingredients. The group has been working with pharmacopoeias around the world on this controversial industry topic. The working group is not expected to address specific tests for heavy metals.

Two new EWGs were formed to focus on genotoxic impurities and photosafety evaluation.

The next ICH meeting of the steering committee and EWGs will be held in Japan in November 2010.