| Category | Description | Typical Examples | Risk | Documentation Need | | :--- | :--- | :--- | :--- | :--- | | | Standard, Non-Configurable | Printer, basic monitor, cable | Very Low | Inventory & Inspection | | 3 | Standard, Configurable | PLC, managed switch, HMI | Medium | Configuration Spec & IQ | | 4 | Custom/Bespoke Hardware | Custom PCB, unique controller | High | Full Design Spec & FAT/SAT |
Detailed design specifications, full qualification (IQ/OQ), and specialized maintenance plans. Hardware Category 1: Standard Components
The focus is on Installation Qualification (IQ) . You must verify that the hardware is the correct model, that it has been installed according to the manufacturer's manual, and that it is maintained in a controlled environment. gamp 5 hardware categories
Inventory record, version control, and verification of correct installation. Custom
includes the vast majority of hardware used in a modern laboratory or manufacturing floor . These components are purchased from a supplier and used exactly as designed. | Category | Description | Typical Examples |
GAMP 5 divides hardware into four distinct categories (1, 2, 3, and 4). Note: Category 2 is legacy and no longer used in GAMP 5 Second Edition (2022), but you will see references in older documents.
GAMP 5 (Good Automated Manufacturing Practice, 5th Edition) uses hardware categories to define the level of validation and maintenance required for physical components within a computerized system. By classifying hardware, organizations can focus their efforts on high-risk, custom-built components while simplifying the lifecycle for standard, off-the-shelf equipment. Overview of GAMP 5 Hardware Categories GAMP 5 divides hardware into four distinct categories
Understanding these categories helps organizations prioritize their validation and maintenance efforts, focusing on the most critical systems that impact product quality, patient safety, and data integrity.