Pharmaceutical Quality Systems

Abstract

Scope: This guideline applies to the systems supporting the development and manufacture of pharmaceutical drug substances (i.e. API) and drug products, including biotechnology and biological products, throughout the product lifecycle. The elements of ICH Q10 should be applied in a manner that is appropriate and proportionate to each of the product lifecycle stages, recognising the differences among, and the different goals of each stage (see section 3). For the purposes of this guideline, the product lifecycle includes the following technical activities for new and existing products: • Pharmaceutical development − Drug substance development; − Formulation development (including container/closure system); − Manufacture of investigational products; − Delivery system development (where relevant); − Manufacturing process development and scale-up; − Analytical method development.