GAMP

GAMP (Good Automated Manufacturing Practice) is a set of guidelines created by the Special Interest Group on Automation of the International Society for Pharmaceutical Engineering (SIGamp). The purpose of GAMP is to provide a framework for the development and validation of automated systems in pharmaceutical and medical device manufacturing.

• GAMP provides a risk-based approach to system validation, which helps manufacturers ensure that their automated systems are reliable and meet regulatory requirements.
• The guidelines cover all stages of the system lifecycle, from planning and development to operation and maintenance.
• The principles outlined in GAMP can be applied to a variety of automated systems, including manufacturing and laboratory equipment, process control systems, and software applications.

By following GAMP guidelines, manufacturers can improve the quality, safety, and effectiveness of their products, as well as reduce the risk of non-compliance with regulatory bodies.