药物递送系统变更评估指南

[中文适用范围]： 本文件为评估和评估与特定药品集成、包装或交叉标记的给药系统的计划变更提供了指导。 本文件适用于药物输送系统从注册临床研究到生命周期结束的整个生命周期。 本文件适用于评估以下给药系统的变化： ——医用针头注射系统； ——气雾剂给药装置； ——医用无针注射器。 注：ISO 11608 系列、ISO 20072 和 ISO 21649 分别涵盖了这些内容。 本文件对于评估和评估其他药物输送装置或系统的变更也可能有用。 本文件范围内的变更示例包括但不限于以下内容： a) 相同的给药途径（例如，导致将市售预充式注射器纳入自动注射器的变更）； b) 药物输送系统设计的改变（例如电气和机械部件的配置或布局的改变）； c) 影响药物输送系统的药品变化；包括主要容器密封件（例如粘度、粒度）； d) 药物输送系统生产或处理的变化（例如工艺规模、手动组装到自动组装、胶粘到声波焊接、模具空化、灭菌、储存、运输、工作指导或方法）； e) 零部件材料或供应来源的变化； f) 软件变更，包括与网络安全、加密和连接相关的变更； g) 用户界面的变化，包括包装； h) 标签和/或使用说明的变更。 软件的修订或添加均在本文档的范围内。 该软件可以集成到物理药物输送系统中，也可以单独集成，或两者兼而有之。 本文档对非集成软件的适用性与这些软件更改可能影响药物输送系统和/或影响用户与其交互的方式相关。 根据变更的性质，可能会有额外的评估和由此产生的活动，这可能超出了本文档的范围。 本文件不提供定义变革目标的指导，也不提供实现此目标的各种潜在机会/选项。  [外文原描述]： 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.