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GAMP 4 is a significant advance on previous versions of this globally accepted guidance. The document has been considerably enhanced, restructured, and refined to reflect current regulatory expectations and good practice.

More than 70 healthcare professionals, from the Americas and Europe, participated in the production of GAMP 4 by contributing to groups producing new and revising existing material. GAMP 4 is intended for suppliers and users in pharmaceutical manufacturing and related healthcare industries such as biotechnology and medical device. The Guide draws together key principles and practices and describes how they can be applied to determine the extent and scope of validation for different types of automated systems.

GAMP 4 helps organizations develop:
validated and compliant automated systems using the concept of prospective validation following a life cycle model
procedures to ensure the automated system remains in a validated state once it is validated and in operation
Benefits of Using GAMP 4 |cost benefits-by aiding the production of systems that are fit for purpose, meet user and business requirements, and have acceptable operation and maintenance costs | better visibility of projects to ensure delivery on time, on budget, and to agreed quality standards | increased understanding of the subject and introduction of a common language and terminology | reductions in the cost and time taken to achieve compliant systems | improved compliance with regulatory expectation by defining a common and comprehensive life cycle model | clarification of the division of responsibility between user and supplier |

For more information, visit www.ispe.org/GAMP

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