Through their efforts, they discovered that the problem was not with the system itself, but with the way it had been validated. They had not followed the GAMP guidelines closely enough, and as a result, the system had not been properly tested.
From that day on, Emma became a champion of GAMP within her company. She worked to ensure that all automated systems were designed, tested, and validated according to the guidelines, and that her colleagues understood the importance of GAMP in ensuring patient safety and product quality.
As she began to dig into the world of automated systems, Emma stumbled upon a mysterious acronym: GAMP. She was intrigued and decided to learn more. what is gamp
One of GAMP's most practical tools is to determine validation effort. GAMP 5 (the current edition) defines four categories:
| Category | Description | Example | Validation Effort | |----------|-------------|---------|--------------------| | | Infrastructure software (OS, database engines, anti-virus) | Windows 11, SQL Server | Record version & configuration | | 3 | Non-configurable software (off-the-shelf, fixed function) | A simple digital thermometer | Moderate – test key functions | | 4 | Configurable software (user-modifiable settings) | ERP system, laboratory information system | High – test configuration & workflows | | 5 | Custom/bespoke software | In-house control code | Highest – full lifecycle validation | Through their efforts, they discovered that the problem
Before GAMP, companies often applied the same rigid, document-heavy validation approach to all systems—from a simple centrifuge to a complex manufacturing execution system (MES). This led to wasted effort, inflated costs, and ironically, overlooked critical risks.
is a set of guidelines published by the International Society for Pharmaceutical Engineering (ISPE) . It is not a legal regulation itself, but rather a practical methodology for validating automated systems. Regulatory bodies like the U.S. FDA and the European Medicines Agency (EMA) accept GAMP principles as an industry standard for demonstrating compliance with Good Manufacturing Practice (GMP). She worked to ensure that all automated systems
GAMP is not simply a checklist to be followed blindly; it is a pragmatic philosophy for quality management. It moves away from the idea that computers are "scary" and towards the idea that computers are reliable tools—if they are built, configured, and tested correctly.
