Good Automated Manufacturing Practices (GAMP) is a set of guidelines published by the International Society of Pharmaceutical Engineering (ISPE) that provides a risk-based framework for validating computerized systems used in pharmaceutical manufacturing. GAMP helps ensure that these systems meet current regulatory requirements for product quality, data integrity, and patient safety.
GAMP may apply to CMMS software used to support pharmaceutical operations, particularly if the system is involved in maintenance tasks that impact equipment used in production. In such cases, the CMMS may need to be validated to demonstrate that it functions as intended and maintains data integrity in compliance with applicable regulatory standards.
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