GAMP 5

GAMP 5 

GAMP5 stands for "Good Automated Manufacturing Practice 5" and it is a set of guidelines and recommendations for computerized systems used in pharmaceutical and healthcare manufacturing. GAMP5 provides a risk-based approach to the validation of computerized systems, including software, hardware, and firmware, used in the manufacturing, testing, and distribution of pharmaceutical products.

 

The GAMP5 guidelines were developed by the International Society for Pharmaceutical Engineering (ISPE) and were first published in 2008. The guidelines provide a framework for ensuring that computerized systems are reliable, consistent, and secure, and that they meet the regulatory requirements of the pharmaceutical and healthcare industries.

 

The GAMP5 guidelines cover a range of topics, including:

 

Risk management and assessment

Validation planning

User requirements

Design and configuration

Testing and acceptance

Operation and maintenance

Change management

Documentation and record-keeping

The GAMP5 guidelines are widely used in the pharmaceutical and healthcare industries and are recognized by regulatory agencies around the world, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).



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