text size:  s  m  l
ICH Step 2 Guidelines

Quality Implementation Working Group on Q8, Q9, Q10

In Brussels 2003 a new quality vision was agreed on. This emphasised a risk and science-based approach to pharmaceuticals in an adequately implemented quality system. As a consequence, the guidelines on Pharmaceutical Development (Q8), Quality Risk management (Q9) and Pharmaceutical Quality System (Q10) were drafted. As these concepts and principles are rather new in the pharmaceutical area, it is important that, due primarily to departure from the traditional approaches to quality guidance, proper implementation of these concepts is provided by bringing clarity, further explanation and removing ambiguities and uncertainties.

In November 2007, the ICH Steering Committee endorsed the establishment of the Quality Implementation Working Group (IWG) to ensure the globally consistent implementation of Q8, Q9 and Q10 and to ensure that maximum benefit is achieved from the interaction between these guidelines.

A first Questions & Answers - document has been developed by the Quality IWG and adopted by ICH Steering Committee in April 2009.

Additional Q&As were developed by the Quality IWG. They were adopted by the ICH Steering Committee in June (second set of Q&As) and in October 2009 (third set of Q&As) then integrated in the Q&A document.

Question and Comments

    


Questions and comments concerning the implementation of Q8, Q9 and Q10 are welcome.  
Please send your questions/comments to the Quality IWG at Q8-9-10@ich.org. Your questions and comments will be discussed at the following plenary session of the Quality IWG. The Quality IWG will continue to develop a Questions & Answers which will be submitted for adoption by the ICH Steering Committee.

 

For further information please see: