DNS/ISO 20069: 2019


Status: Public comments
Start date: 20240718
End date: 20240916

This document provides guidance for assessment and evaluation of planned changes to drug delivery  systems that are integral with, packaged with, or cross-labelled for use with a specified medicinal  product. This document is applicable to the drug delivery system’s lifecycle from registration clinical  studies to end-of-life. This document is applicable to the assessment of changes within the following  drug delivery systems:  

— needle-based injection systems for medical use; 

— aerosol drug delivery devices; 

— needle-free injectors for medical use. 

NOTE  These are covered by the ISO 11608 series, ISO 20072 and ISO 21649, respectively. 

This document might also be useful for assessing and evaluate changes to other drug delivery devices  or systems. 

Examples of changes that are within the scope of this document include but are not limited to the  following: 

a) the same route of administration (e.g. change resulting in including a marketed prefilled syringe to  an autoinjector); 

b) changes to the drug delivery system design (e.g. change in configuration or layout of electrical and  mechanical components); 

c) changes to the medicinal product that affect the drug delivery system; including the primary  container closure (e.g. viscosity, particle size); 

d) changes in production or handling of the drug delivery system (e.g. process scale, manual  to automated assembly, glue bond to sonic weld, mould cavitation, sterilization, storage,  transportation, work instructions or methods); 

e) changes in component materials or source of supply; 

f) changes in software, including changes related to cybersecurity, encryption and connectivity; g) changes in the user interface, including packaging; 

h) changes to labelling and/or instructions for use. 

Revisions or additions of software are within the scope of this document. The software can either be  integrated into the physical drug delivery system, separate, or both. 

The applicability of this document to non-integrated software is relevant to the extent that those  software changes can impact the drug delivery system and/or impact how users interact with it. 

Depending on the nature of the change, there can be additional assessments and resulting activities,  which can be outside the scope of this document. 

This document does not provide guidance for defining the objective of the change, nor the various  potential opportunities/options for fulfilling this objective. 

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