ISPE Releases IT GAMP Good Practice Guide

The International Society for Pharmaceutical Engineering (ISPE) released the ISPE GAMP Good Practice Guide: IT Infrastructure Control and Compliance (Second Edition), the group announced in an Aug. 31, 2017 press release. This guide provides guidance on meeting regulatory expectations for both traditional and cloud-based information technology (IT) Infrastructure platforms.

“The creation of this guide was facilitated by a large cross section of SMEs [subject matter experts] from the life science community, cloud practitioners, regulated companies, consultants, and global regulatory authorities,” said Steve Ferrell, team lead for the Guide, in the press release. “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 guide 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:

• virtualization technologies that allow the sharing of resources

• cloud computing, including three cloud-based service models

• delivery of GxP applications “as-a-service”

• outsourcing and increased use of third party datacenters.

Source: ISPE