Explain about GAMP 5 Guideliness
Can anyone Explain about GAMP 5 Guidelines of CSV systems?
Replies to this topic (1)
GAMP 5 is called as Good Automated Manufacturing Practices. 5 represents its version number.
GAMP is usage of computerised systems and software for easing the work for an User.
It is used for Digital systems, LIMS, OS, and for specific requirement like websites and all.
As you see, GAMP is the guidelines system that ensures the quality and meeting expectations for the systems for intended use.
GAMP 5 makes sure that how the risk assessments and complexity validation that can a system like computer or software can make to ensure the use.
In brief, GAMP is the usage of Automated systems like Robotic functioning and is in better way and automating the work by minimising Human involvement.
GAMP 5 is classified based on complexity and risk as follows:
| S.No | Category | Name | Application |
| 1 | Category 1 | Infrastructure software | Operating systems |
| 2 | Category 3 | Non configured products | COTs like Digital balances and Lab systems |
| 3 | Category 4 | Configured products | LIMS, SCADA, DCS |
| 4 | Category 5 | Custom applications | Unique Batch record software specified to Customer and their requirement |