GAMP

GAMP stands for Good Automated Manufacturing Practice and it is a set of guidelines developed by the International Society for Pharmaceutical Engineering (ISPE) to ensure the effective use of automated systems in pharmaceutical manufacturing.

GAMP was developed by the Special Interest Group for Automation of the ISPE (SIGamp), which is a global organization of pharmaceutical professionals dedicated to promoting best practices in automated manufacturing systems.

The purpose of GAMP is to provide industry-accepted guidance for the validation and compliance of automated systems, ensuring they are fit for their intended use and meet regulatory requirements.

GAMP covers various aspects of automated systems, including validation methodologies, risk management, quality management, data integrity, software development lifecycles, and supplier management.

Pharmaceutical manufacturers, equipment suppliers, system integrators, and anyone involved in the development, implementation, or maintenance of automated systems in the industry should follow GAMP guidelines.

GAMP guidelines are periodically updated by SIGamp to keep pace with evolving industry practices, technology advancements, and regulatory requirements.

GAMP 5 is the latest version of the GAMP guide published by ISPE. It provides a risk-based approach to validation and emphasizes the integration of automated systems with quality management systems.

GAMP guidelines are not regulations themselves, but they provide industry best practices that align with regulatory expectations. Following GAMP helps organizations comply with regulations such as FDA's 21 CFR Part 11 and EU's Annex 11.

While GAMP was initially developed for the pharmaceutical industry, its principles and guidelines are also applicable to other regulated industries that use automated systems, such as biotechnology, medical devices, and food manufacturing.

GAMP guidelines can be accessed through the ISPE website or by becoming a member of SIGamp, which provides access to exclusive resources, training, and networking opportunities.