GAMP – Software
Good Automated Manufacturing Practices
GAMP (Good Automated Manufacturing Practices) refers to the analysis of computer-supported systems in the pharmaceutical industry to assess whether they follow the stipulated guidelines that maintain operational efficiency and reliability.
How does it work?
GAMP® refers to Good Automated Manufacturing Practice.
A GAMP software audit is an internal or external review of a computerized system to check its quality, progress, or adherence to plans, standards, and regulations. The process is conducted by either internal teams or by one or more independent auditors.
GAMP software is a system for producing quality equipment using the concept of prospective validation following a life cycle model. Specifically designed to aid suppliers and users in the pharmaceutical industry.
The categories of GAMP (software) are Infrastructure software, Non- Configurable Software, Configured Software, and Bespoke Software; therefore, the audit shall check for validity of the software per category.