什么是共包装产品？
根据FDA的“两个或多个独立的物品，在一个容器中或作为一个单位包装在一起，由药物和设备产品，设备和生物产品或生物和药物产品组成”，是由共包装产品组成的。送货设备，绷带和抗菌拭子都是设备项目的示例。了解管理此类设备的法规可能很困难，因此，制药公司在提交之前经常向设备制造商/提供商寻求帮助。
Examples of co-packaged combination products：
one example of a co-packaged combination product is an inhaler with filled drug cartridge, which combines two components, an inhaler device and a drug, into a single container.
- 具有输送机制的药物，即雾化器，吸入器，滴管或注射器
- Convenience kits i.e., first aid kits or surgery kits
此前,引用一个特定的设备登记,such as a 510(k), was sufficient. Things have changed in recent years, with expectations extending far beyond a device’s Design History File. It’s important to think about how the device and medicine will work together as a “system.” Functionality, compatibility, and human factors testing must show that the technology and medicine operate together to produce a positive result.
For the co-packaged combination product manufacturer implement streamlined approach which include drug and device by demonstrating compliance with either drug CGMPs 21CFR part210and211 or Device QSR21cfrpart 820为了证明合规制造商需要识别文档，许多次制造商不知道如何为此创建文档，在这里我们的专家团队通过为正确的QSR提供指导来帮助他们。
The testing must account for the production and administration of a medicine using all of the intended components and resources. Any primary containment system components, such as vials and stoppers, as well as syringes, would fall under this category. When possible, testing should take into account the actual drug product, or the drug product plus diluent if a reconstitution step is required, and it should be done according to industry standards (ISO, USP, ASTM, etc.). However, not every device/drug combination may have a standard.
在这种情况下，应进行测试旨在评估药物生产和分销过程的所有基本特征，并应在可能的情况下基于或参考行业标准。
Devices are more important than ever before in many drug applications. A co-packaged combination product must be examined as a whole, not only as individual components, and testing that verifies successful drug administration will be required. West has the unique knowledge and skills required for creating and performing studies to support co-packaged combination products as a global device developer and producer as well as a contract analytical services provider.
类型s of Combination Product
下表构建了识别和定义可用的九种组合产品。仅包含医疗设备的软件包不是组合产品。此外，仅由药物组成的产品不是组合产品。如果您的产品似乎不满足以下频繁实例，或者您对联合产品类别的表格1571和365H有疑问，请联系您中心的产品管辖权官员。
| 类型 | 描述 | 常见的例子 |
| 1 | Convenience Kit or Co-Package 在同一包装中提供药物和设备作为单个组成部分 |
Convenience Kit or Co-Package 具有设备组成部分的共包装组合产品的制造商必须设置并维护根据21 CFR 820.100强加CAPA的方法。 |
| 2 | Prefilled Drug Delivery Device/ System 药物被填充或以其他方式与设备结合在一起，该设备的唯一目的是输送药物 |
Prefilled drug syringe, auto-injectors, metered-dose inhalers, dry powder inhalers, nasal spray etc. |
| 3 | Prefilled Biologic Delivery Device/ System 生物产品被填充或以其他方式与设备结合使用，该设备的唯一目的是提供生物产品。 |
Vaccine or other biological product in a prefilled syringe, auto-injector, nasal spray, |
| 4 | 设备涂层/浸渍/其他与药物结合 设备除了输送药物外具有附加功能 |
Drug pills embedded with sensors, contact lens coated with a drug, drug-eluting stents, drug-eluting leads, condoms with spermicide, dental floss with fluoride |
| 5 | 设备涂层或以其他方式与生物学结合 设备除了输送药物外具有附加功能 |
Live cells seeded on or in a device scaffold, extracorporeal column with column-bound protein |
| 6 | 药物/生物学组合 | 抗体 - 药物结合物，祖细胞与药物结合以促进归巢 |
| 7 | Separate Products Requiring Cross Labeling | Light-activated drugs or biological products not co-packaged but labeled for use with a specific light source device |
| 8 | 基于单独产品的交叉标记的可能组合 | 开发中的药物/生物产品利用了设备，但不清楚最终产品是否需要两者进行交叉标签 |
| 9 | 其他类型的第3部分组合产品（例如，药物/设备/生物产品） Combination product not otherwise described |
All 3 articles are combined in a single product (e.g., a prefilled syringe containing an antibody-drug conjugate), device to manufacture a biologic also includes a drug or biologic in the kit, or the product contains two different combination product types (e.g., Type 1 and Type 2 are provided together |
“组合产品”一词是指包含药物作为组成部分的医疗设备，因此，将正确的法规应用于这些方面可能具有挑战性。医疗设备的制造和销售需要在监管领域进行广泛的研究，但对于每个制造商来说都是不可能的。作为一个medical device regulatory consultant我们指导他们并提供监管服务以使他们的道路顺利。
