DANSK DSF/ISO/FDIS 20069 PDF

This document provides guidance to assess and evaluate changes to drug delivery systems that are integral with, packaged with, or cross-labelled for use with a specified medicinal product. The guidance applies to the drug delivery system’s lifecycle from pivotal/registration clinical studies to end-of-life. The guidance applies to the following drug delivery systems within the scope of technical committee ISO/TC 84: – ISO 11608- series 'Needle based injection systems for medical use'; – ISO 20072 'Aerosol drug delivery device design verification – Requirements and test methods'; – ISO 21649 'Needle-free injectors for medical use -- Requirements and test methods'. This document might also be useful for assessing changes to other devices intended for administration of medicinal products beyond those specified above.