药品组合产品
药品组合产品FDA Guidance
联合产品由《联邦法规法典》所示，CFR被表示为包括医疗设备 /或药物 /或生物学合并这些分类中的任何两种的产品，甚至在某个时候甚至三个分类中的每个分类。众所周知的组合产品项是洗脱支架（DES），它是一个被药物覆盖的支架，以防止疤痕组织在供应动脉中发育。大多数人对组合产品的看法有限。如今，组合产品正在开发中，其中包括更多的东西，不仅仅是药物，设备或生物产品，医疗设备。它们包括食物，包括营养素和化妆品，或被认为是宇宙剂。将药物与设备结合的产品称为药物装置组合。
As per the FDA combination product ,types of combination product can be, single entity, cross labelled, co-packaged.
Combination Products example like prefilled syringes, applicators of the tropical products. manufactures shall have adequate design and development activity done so as to prove the adequacy of the safety and efficacy of the product. The医疗设备设计和开发活动是系统的方法，它可以建立产品的正确设计和开发。在医疗设备或组合设备的情况下，许多客户投诉和483个投诉都导致了设计和开发控制活动的不当。产品的设计和开发要求在 ISO 13485：2016 and 21 CFR Part 820 also. As per theUS FDA 21 CFR，单独包装的产品包装在一起，并将其作为生物和药物产品，设备和生物产品或药物和设备产品称为共包装组合产品。在fda的简介中，组合产品是结合药物，设备和/或生物产品的治疗和诊断产品
Combination Products Project Development Process & Design Control
制造商的制药公司s the combination products are expected to implement the 21 CFR Part 210 and 211 and 21 CFR Part 820 for their manufacturing sites of the combination products. At the end of the design Phases, the DHF is compiled and shall be presented during the audits. The DMR shall be extracted from the DHF for the routine use and the tech transfer. The requirements mentioned in the DMR shall be used to create the DHR to demonstrate the routine production and compliances. As per the requirements of the ISO 13485:2016, the medical device file shall be established. The complexity of the design procedure is dependent on the Product complexity and intended use. The design control is a vital part as far as the Quality Management System goes.
Drug-Device Combination (DDC) as per MDR for CE Marking
积分DDC是属于第1（8）条和《医疗设备》（MDR）第1（8）条和第1（9）第62条（EU）第1（9）条第62条的产品。
通常，这些设备具有测量，计量或输送功能。
Examples of medical devices in integral DDCs are:
- Devices for delivery to the site of action e.g. the dropper on the top of the container with eye drops the mouthpiece on the top of spray cans for throat sprays.
- Single-dose pre-filled syringes, pens and injectors.
- Multi-dose pens and injectors containing a pre-filled cartridge where the cartridge cannot be replaced, and the pen is not designed for subsequent use with a new cartridge.
- Drug-releasing intra-uterine devices; pre-assembled, non-reusable applicators for vaginal tablets.
- 与药用成分组装并准备与单剂量或多剂一起使用但在服用所有剂量时无法添加的干粉吸入器。
- 主要目的是释放药用产品的植入物。
Examples of medical devices in integral DDCs are:
- 口服给药设备（例如杯子，汤匙，注射器）
- 注射针和过滤针头
- 可再填充笔和喷油器（例如使用墨盒）。
- Reusable dry powder inhalers; spacers for inhalation sprays
- 药品输送泵
- 电子片剂分配器
医疗设备的每个制造商都应建立并维护以下程序
- Control the design of the device
- Ensure that specified design requirements are met
CAPA Management For Combination Products
CAPA管理药物和设备组合产品的内容如下：
确保设备符合组合产品的要求
- 用户的需求和预期用途
- 要求和规格
- 组合产品的监管途径
- 可以可重复地可靠地制造，维修和/或安装。
Tools for Archiving Purpose of Combination Products
- 建立设计控制程序。
- Develop plans for Design Projects(Include interfaces between R&D and other units)
- Identify design inputs requirements and high-level specifications for the device
- Develop design outputs (to final specifications)
- 通过测量，分析，测试或检查所有设计输出满足输入要求的设计验证。
- 将产出转移到生产
- Design Validation that the device performs and functions as intended and as users need an expert.
- Control changes during design and development and to existing devices Document design activities in the design history file.
operon Strategist as a reliablemedical device consultant通过提供支持药物磁盘组合产品注册的咨询服务来协助公司和医疗设备制造商。我们拥有每个组成部分和GMP法规的经验，共同构成了其开发和制造的基础：药物（21 CFR 210/211），设备（21 CFR 820）和21 CFR组合产品（21 CFR Part 4）