GAMP stands for Good Automated Manufacturing Practice.
This acronym refers to a set of guidelines and principles used primarily in the pharmaceutical industry to ensure that automated systems are reliable, consistent, and meet regulatory requirements. These guidelines help ensure the quality and safety of pharmaceutical products by focusing on the validation and life cycle management of automated systems used in manufacturing processes. GAMP is a technical sub-committee of the International Society for Pharmaceutical Engineering (ISPE).
In essence, GAMP provides a structured framework for:
- Planning and Design: Defining user requirements and specifications for automated systems.
- Development and Configuration: Implementing and configuring systems according to those requirements.
- Validation and Testing: Demonstrating that the system performs as intended and meets regulatory standards.
- Maintenance and Change Management: Ensuring the system continues to operate reliably and safely over time.
By following GAMP guidelines, pharmaceutical manufacturers can reduce the risk of errors, improve the efficiency of their operations, and ensure compliance with regulatory requirements like those from the FDA (Food and Drug Administration) and EMA (European Medicines Agency).
