ISPE Releases GAMP® Good Practice Guide: IT Infrastructure Control and Compliance (Second Edition)

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This guide provides guidance on meeting regulatory expectations for compliant IT Infrastructure platforms, both traditional and cloud-based.

, ISPE GAMP® Good Practice Guide: IT Infrastructure Control and Compliance (Second Edition)
The creation of this guide was facilitated by a large cross section of SME’s from the Life Science community, cloud practitioners, regulated companies, consultants, and global regulatory authorities.

The International Society for Pharmaceutical Engineering (ISPE) announced the release of their latest guidance document, ISPE GAMP® Good Practice Guide: IT Infrastructure Control and Compliance (Second Edition). This guide provides guidance on meeting regulatory expectations for compliant IT (Information Technology) Infrastructure platforms, both traditional and cloud-based.

“The creation of this guide was facilitated by a large cross section of SME’s from the Life Science community, cloud practitioners, regulated companies, consultants, and global regulatory authorities,” said Steve Ferrell, Guide Team Lead. “It aligns with GAMP® 5 and expands the scope of the original Good Practice Guide to include guidance on the emergence of cloud and virtualized technologies.”

The ISPE GAMP® Good Practice Guide: IT Infrastructure Control and Compliance (Second Edition) applies a structured approach, including risk management, to the qualification, management, and control of IT Infrastructure platforms. It also offers a scalable framework which can be applied to different platform types to determine the scope of qualification efforts. In addition, it contains an overview of industry best practices for the design, qualification, and operation of an IT Infrastructure with emphasis on the qualification requirements of the major components.

Updated information has been added to reflect the changes in the technologies that make up IT Infrastructure, including:

  • The use of virtualization technologies that allows the sharing of resources
  • The use of cloud computing, including three cloud-based service models
  • The delivery of GxP applications “as-a-service”
  • The outsourcing and increased use of third party datacenters

Find the newly released, ISPE GAMP® Good Practice Guide: IT Infrastructure Control and Compliance (Second Edition) at http://www.ISPE.org/Publications/Guidance-Documents.

About ISPE
The International Society for Pharmaceutical Engineering (ISPE) is the world’s largest not-for-profit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical life cycle. The more than 18,000 members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Bethesda, Maryland USA, and an operations and training center in Tampa, Florida USA. Visit http://www.ISPE.org for more information.

For more information contact:
Maria Robertson
Senior Director, Marketing Communications
International Society for Pharmaceutical Engineering (ISPE)
Tel: +1-301-364-9207
Email: mrobertson(at)ispe(dot)org
http://www.ISPE.org

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Maria Robertson
ISPE
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