A kit that includes two or more different types of medical products (e.g., a device and a drug) is a co-packaged combination product and, therefore, part 4 applies to the manufacture of the kit. The CGMP requirements applicable to a kit manufacturer depend on what products are included in the kit.
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Overview
Features:
- First aid and trauma care tools
- Includes splints and wraps
- Durable, shockproof case
- Organized with removable sections
- Versatile usage labels
