Current ICH quality developments

For some time I have reported on the development of the various quality guidelines developed under the ICH (International Conference on Harmonisation) process. In particular over the past few years it has concentrated on the preparation of the Guidelines Q8 (Pharmaceutical Development), Q9 (Quality Risk Management) and Q10 (Pharmaceutical Quality System), which have aimed to give an integrated approach to quality aspects of the lifecycle of a product and to help both manufacturer and regulator achieve this through a greater understanding at an early stage of the product's characteristics and its manufacturing processes.

Practical implementation of these principles is now an area of great discussion in pharmaceutical development and quality and regulatory circles and the ICH process has sought to facilitate this process through the setting up of a Quality Implementation Working Group (IWG) to consider questions raised by users of the guidelines. Users with any questions for the Implementation Group can forward these to the IWG via the ICH website.

It is intended to give help on the questions raised by enquirers via Question and Answer Guidance produced by the IWG. Guidelines Q8, Q9 and Q10 relate largely to development and manufacture of the finished product. A new quality guideline, Q11, on Development and Manufacture of Drug Substances (chemical entities and biotechnological/biological entities) is now being developed in an effort to apply the principles set out in the Guidelines Q8, 9 and 10 to active pharmaceutical ingredients. Details of the rationale for the development of this new guideline are set out in a concept paper.

Updates on the development of Q11 will appear in future issues.