GAMP 5 Software Categories
GAMP 5 categorizes software used in the pharmaceutical and biotechnology industries into five categories (Category 1 to Category 5) based on their impact on product quality, patient safety, and regulatory compliance. Each category has specific validation requirements and considerations. Here's an expanded explanation of each category:
Category 1 - Infrastructure Software:
- Definition: Infrastructure software includes operating systems, database management systems, and network infrastructure components.
- Validation Focus: The primary focus for Category 1 software is on ensuring the integrity and reliability of the infrastructure that supports pharmaceutical processes. This includes verifying that the software is installed correctly and maintained in a validated state.
- Validation Requirements: Validation of Category 1 software typically involves installation qualification (IQ) and operational qualification (OQ) to ensure that the software and hardware components operate as intended.
Category 2 - Non-configured Software:
- Definition: Non-configured software includes commercial off-the-shelf (COTS) software packages that are used without configuration or with minimal configuration.
- Validation Focus: For Category 2 software, the focus is on ensuring that the software functions as intended without introducing unintended changes or configuration issues.
- Validation Requirements: Validation typically involves IQ, OQ, and sometimes performance qualification (PQ) to demonstrate that the software performs as specified by the vendor.
Category 3 - Configured Software:
- Definition: Configured software includes software that is configured to meet specific user requirements, often through settings, parameters, or scripting.
- Validation Focus: Category 3 software validation involves verifying that the configured software meets user requirements and functions reliably.
- Validation Requirements: In addition to IQ and OQ, Category 3 software validation includes validating the configuration settings (configuration qualification or CQ) to ensure they meet user requirements and that the software operates as expected.
Category 4 - Bespoke Software:
- Definition: Bespoke software refers to custom-developed software applications specifically designed for a particular pharmaceutical process or system.
- Validation Focus: Category 4 software validation is extensive and focuses on ensuring that the custom-developed software is fit for its intended purpose, doesn't introduce errors, and complies with regulatory requirements.
- Validation Requirements: Bespoke software validation includes IQ, OQ, PQ, and user acceptance testing (UAT). Extensive documentation, including detailed specifications, design documentation, and validation protocols, is required.
Category 5 - Hardware/Software Systems:
- Definition: Category 5 encompasses hardware and software systems where both components are tightly integrated and essential to the pharmaceutical process (e.g., process control systems).
- Validation Focus: Validation of Category 5 systems focuses on ensuring the entire system operates reliably and meets user and regulatory requirements.
- Validation Requirements: The validation of Category 5 systems is comprehensive and includes IQ, OQ, PQ, UAT, and sometimes factory acceptance testing (FAT) to verify that the system performs as expected.
It's important to note that the level of validation rigor and documentation increases as you move from Category 1 to Category 5. The choice of category for a particular software system depends on factors such as its criticality to product quality, the potential impact of failures, and regulatory requirements. Validation activities for each category should be well-documented and compliant with GMP (Good Manufacturing Practices) and other relevant regulations.