Federal Register Notice: FDA is making available a draft guidance entitled Q10 Pharmaceutical Quality System prepared under the auspices of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The document applies to drug substances and drug products, including biotechnology and biological products, and describes a model for an effective quality management system for the pharmaceutical industry, referred to as the Pharmaceutical Quality System. It is intended to provide a comprehensive approach to an effective pharmaceutical quality system that is based on International Organization for Standardization concepts, includes applicable GMP regulations, and complements the ICH guidances on Q8 Pharmaceutical Development and Q9 Quality Risk Management. To download this guidance, click here. To view this notice, click here.