BS ISO 20069:2019 PDF

Scope: What is ISO 20069- Changes to drug delivery systems about? ISO 20069 discusses drug delivery systems. ISO 20069 is an international standard on guidance regarding changes to drug delivery systems. ISO 20069 provides guidance for the assessment and evaluation of planned changes to drug delivery systems that are integral with, packaged with, or cross-labeled for use with a specified medicinal product. ISO 20069 applies to the drug delivery system’s lifecycle from registration clinical studies to end-of-life. ISO 20069 applies 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 1: The applicability of ISO 20069 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. Note 2: Depending on the nature of the change, there can be additional assessments and resulting activities, which can be outside the scope of ISO 20069 . Note 3: ISO 20069 ...

BS ISO 20069:2019 history

2019 BS ISO 20069:2019 Guidance for assessment and evaluation of changes to drug delivery systems