Annex 2 Diagram of the ICH Q10 Pharmaceutical Quality System Model

This diagram illustrates the major features of the ICH Q10 Pharmaceutical Quality System ( PQS ) model .The PQS covers the entire lifecycle of a product including pharmaceutical development , technology transfer , commercial manufacturing , and product discontinuation as illustrated by the upper portion of the diagram .The diagram also illustrates that regional GMPs apply to the manufacture of investigational products .The bottom set of horizontal bars illustrates the enablers knowledge management and quality risk management , which are applicable throughout the lifecycle stages .