ICH Q10 - Pharmaceutical Quality System

Pharmaceutical Quality Systems Handbook - The tripartite harmonized ICH guideline was finalized (Step 4) in June 2008 - This guideline applies to pharmaceutical drug substances and drug products, including biotechnology and biological products, throughout the product life-cycle. The elements of Q10 should be applied in a manner that is appropriate and proportionate to each of the product life-cycle stages, recognizing the differences among, and the different goals of each stage.