ISO 20069:2019 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.
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Edition: 1.0 Published: 08/01/2019 Number of Pages: 44 File Size: 1 file , 1.8 MB Same As: BS ISO 20069:2019
