Zdrowie i gospodarka · 13/07/2007

International Conference on Harmonisation; Draft Guidance on Q10 Pharmaceutical Quality System; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "Q10 Pharmaceutical Quality System." The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance describes a model for an effective quality management system for the pharmaceutical industry, referred to as the Pharmaceutical Quality System. The draft guidance applies to drug substances and drug products, including biotechnology and biological products, throughout the product lifecycle. The draft guidance is intended to provide a comprehensive approach to an effective pharmaceutical quality system that is based on International Organization for Standardization (ISO) concepts, includes applicable good manufacturing practice (GMP) regulations, and complements the ICH guidances on "Q8 Pharmaceutical Development" and "Q9 Quality Risk Management."