标准编号：ISO 20069:2019
中文名称：评估和评价药物递送系统变化的指南
英文名称：Guidance for assessment and evaluation of changes to drug delivery systems
发布日期：2019-08
标准范围
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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