Q10, pharmaceutical quality

ICH Q10. Pharmaceutical Quality System, ICH Harmonised Tripartite Guideline, Current Step 2, 09th May 2007. http //www.fda.gov/downloads /Regulatorylnformation/ Guidances/ucm 128031.pdf. Accessed on 04th September 2012. 

Three consensus guidelines define the core of the ICH s involvement in harmonization of pharmaceutical quality systems—Q8 Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality Systems (in addition, each of the guidance documents cites critical areas of overlap with Q6A Specifications Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products Chemical Substances). 

International Conference on Harmonization (ICH) (2005), Q10 Pharmaceutical quality systems, final concept paper, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH, Geneva. 

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