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GAMP

GAMP

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**GAMP**

What is GAMP?

GAMP (Good Automated Manufacturing Practice) is a set of guidelines for computer system validation in the pharmaceutical industry. It provides a structured approach to ensuring that computerized systems used in regulated environments are fit for their intended purpose and comply with regulatory requirements, such as those from the FDA (in the US) and EMA (in Europe). The GAMP 5 guideline is the current version and promotes a risk-based approach to validation, focusing on system criticality and impact on product quality.

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